HD CAMERA HEAD OTV-S7PROH-HD-L08E

Endoscopic Video Imaging System/component, Gastroenterology-urology

OLYMPUS MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Hd Camera Head Otv-s7proh-hd-l08e.

Pre-market Notification Details

Device IDK083155
510k NumberK083155
Device Name:HD CAMERA HEAD OTV-S7PROH-HD-L08E
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
ContactStacy A Kluesner
CorrespondentStacy A Kluesner
OLYMPUS MEDICAL SYSTEMS CORPORATION 3500 CORPORATE PARKWAY Center Valley,  PA  18034 -0610
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-24
Decision Date2009-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170268267 K083155 000

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