federal_register: 2013-00085

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2013-00085 Cardiovascular Devices; Reclassification of External Cardiac Compressor Proposed Rule The Food and Drug Administration (FDA) is proposing to reclassify the external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III devices into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended. 2013-01-08 2013 1 https://www.federalregister.gov/documents/2013/01/08/2013-00085/cardiovascular-devices-reclassification-of-external-cardiac-compressor https://www.govinfo.gov/content/pkg/FR-2013-01-08/pdf/2013-00085.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is proposing to reclassify the external cardiac compressor, including cardiopulmonary resuscitation (CPR) aids, from class III devices into class II (special controls). FDA is proposing this reclassification on...  

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