FDA 510(k) K122831, VIDEO SYSTEM CENTER, OLYMPUS MEDICAL SYSTEMS CORP.

FDA 510(k) K122831, VIDEO SYSTEM CENTER, OLYMPUS MEDICAL SYSTEMS CORP.

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510(K) Number: K122831
Device Name: VIDEO SYSTEM CENTER
Manufacturer: OLYMPUS MEDICAL SYSTEMS CORP.
Device Classification Name: Led Light Source
Regulation Number: 876.1500
Classification Product Code: NTN
Date Received: 09/17/2012
Decision Date: 12/14/2012
Regulation Medical Specialty: Gastroenterology/Urology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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