FDA 510(k), K923160, 3DSCOPE

FDA 510(k), K923160, 3DSCOPE

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510(K) Number: K923160
Device Name: 3DSCOPE
Manufacturer:
Device Classification Name: Camera, Television, Endoscopic, Without Audio
Regulation Number: 878.4160
Classification Product Code: FWF
Date Received: 06/29/1992
Decision Date: 12/10/1992
Regulation Medical Specialty: General & Plastic Surgery

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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