FDA 510(k), K842607, INFANT APNEA BED STIMULATOR AA-010

FDA 510(k), K842607, INFANT APNEA BED STIMULATOR AA-010

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510(K) Number: K842607
Device Name: INFANT APNEA BED STIMULATOR AA-010
Manufacturer:
Device Classification Name:
Regulation Number:
Classification Product Code: KXA
Date Received: 07/05/1984
Decision Date: 09/13/1984
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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