{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Pulse Oximeters--Premarket Notification Submissions [510(k)s].\" This guidance document pertains to non-invasive pulse oximeters intended for prescription use to measure arterial blood oxygen saturation (SpO<INF>2</INF>) and pulse rate. This document supersedes the General Guidance Document entitled \"Device: Non-Invasive Pulse Oximeter\" issued on September 7, 1992, and represents the Agency's current thinking in regards to information that should be included in a premarket submission for a non-invasive pulse oximeter.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2013/03/04/2013-04870.html","cfr_references":[],"citation":"78 FR 14097","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0205 (Formerly 2007D-0252)"],"dockets":[],"document_number":"2013-04870","effective_on":null,"end_page":14097,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/03/04/2013-04870.xml","html_url":"https://www.federalregister.gov/documents/2013/03/04/2013-04870/pulse-oximeters-premarket-notification-submissions-510ks-guidance-for-industry-and-food-and-drug","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-04870?publication_date=2013-03-04","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-03-04/2013-04870/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":323,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-03-04/pdf/2013-04870.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-04870.pdf?1362145739","publication_date":"2013-03-04","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/03/04/2013-04870.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2007-D-0205","supporting_documents_count":0,"docket_id":"FDA-2007-D-0205","regulation_id_number":null,"title":"Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters - Premarket Notification Submissions 510(k)s","checked_regulationsdotgov_at":"2013-03-24T06:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":14097,"subtype":null,"title":"Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Pulse Oximeters; Premarket Notification Submissions","toc_subject":"Guidance for Industry and Staff; Availability:","topics":[],"type":"Notice","volume":78}