4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA

Endoscopic Video Imaging System/component, Gastroenterology-urology

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for 4k Camera Head Olympus Ch-s400-xz-eb, 4k Autoclavable Camera Head Olympus Ch-s400-xz-ea.

Pre-market Notification Details

Device IDK172817
510k NumberK172817
Device Name:4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA
ClassificationEndoscopic Video Imaging System/component, Gastroenterology-urology
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentSheri L. Musgnung
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeFET  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-18
Decision Date2017-10-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170375552 K172817 000
04953170374609 K172817 000

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