FDA 510(k), K101801, MONICA AN24

FDA 510(k), K101801, MONICA AN24

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510(K) Number: K101801
Device Name: MONICA AN24
Manufacturer:
Device Classification Name: Uterine Electromyographic Monitor
Regulation Number: 884.2720
Classification Product Code: OSP
Date Received: 06/28/2010
Decision Date: 02/03/2011
Regulation Medical Specialty: Obstetrics/Gynecology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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