FDA 510(k), K831459, FETAL BLOOD SAMPLING KIT #1560

FDA 510(k), K831459, FETAL BLOOD SAMPLING KIT #1560

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510(K) Number: K831459
Device Name: FETAL BLOOD SAMPLING KIT #1560
Manufacturer: TRANSIDYNE GENERAL CORP.
Device Classification Name: Sampler, Blood, Fetal
Regulation Number: 884.1560
Classification Product Code: HGW
Date Received: 05/06/1983
Decision Date: 06/30/1983
Regulation Medical Specialty: Obstetrics/Gynecology

Total Pages: 89
Fully Redacted Pages: 83
Content Pages: 6

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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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