id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id FDA-2014-N-1209-0315,FDA,FDA-2014-N-1209,Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/ or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression,Rule,Final Rule,2019-12-20T05:00:00Z,2019,12,2019-12-20T05:00:00Z,,2019-12-20T13:47:06Z,2019-27295,0,0,0900006484240022 FDA-2014-N-1209-0313,FDA,FDA-2014-N-1209,Fisher Wallace Memo January 9,Supporting & Related Material,Memorandum,2017-02-02T05:00:00Z,2017,2,,,2017-02-02T14:47:31Z,,0,0,09000064824a545f FDA-2014-N-1209-0314,FDA,FDA-2014-N-1209,Letter accompanying Submission to Proposed Order Docket FWL,Supporting & Related Material,Letter,2017-02-02T05:00:00Z,2017,2,,,2017-02-02T14:48:12Z,,0,0,09000064824a5460 FDA-2014-N-1209-0003,FDA,FDA-2014-N-1209,"Reference 33, Studies of Electrosleep on Normal Adults, Insomniacs, and Hypertensive Patients re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression",Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T17:55:45Z,,0,0,0900006481e2919e FDA-2014-N-1209-0005,FDA,FDA-2014-N-1209,"Reference 31, Does Electrosleep Induce Natural Sleep? re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression",Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T17:56:07Z,,0,0,0900006481e2919c FDA-2014-N-1209-0001,FDA,FDA-2014-N-1209,Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2016-01-22T05:00:00Z,2016,1,2016-01-22T05:00:00Z,2016-04-22T03:59:59Z,2016-06-15T01:00:33Z,2016-01173,0,0,0900006481e2882d FDA-2014-N-1209-0007,FDA,FDA-2014-N-1209,Reference 30 Quantitative EEG Analysis of Electrosleep Using Analog Frequency Analyzer and Digital Computer Methods re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression,Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T17:57:04Z,,0,0,0900006481e29196 FDA-2014-N-1209-0009,FDA,FDA-2014-N-1209,"Reference 2 - FDA Executive Summary, Prepared for the February 10, 2012, meeting of the Neurological Devices Panel re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression",Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T18:05:28Z,,0,0,0900006481e28c87 FDA-2014-N-1209-0006,FDA,FDA-2014-N-1209,"Reference 35, A Clinical Trial of Cranial Electrotherapy Stimulation for Anxiety and Comorbid Depression re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression",Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T17:56:55Z,,0,0,0900006481e290f4 FDA-2014-N-1209-0002,FDA,FDA-2014-N-1209,List of References re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression,Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T17:55:33Z,,0,0,0900006481e28c37 FDA-2014-N-1209-0004,FDA,FDA-2014-N-1209,"Reference 32, Ineffectiveness of Elctrosleep in Chronic Primary Insomnia re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression",Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T17:55:56Z,,0,0,0900006481e2919d FDA-2014-N-1209-0008,FDA,FDA-2014-N-1209,"Reference 1 - Transcript, February 10, 2012, meeting of the Neurological Devices Panel of the Medical Device Advisory Committee re Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression",Supporting & Related Material,Background Material,2016-01-22T05:00:00Z,2016,1,,,2016-01-22T18:03:24Z,,0,0,0900006481e28c86