Airway Mobilescope

Bronchoscope (flexible Or Rigid)

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Airway Mobilescope.

Pre-market Notification Details

Device IDK201300
510k NumberK201300
Device Name:Airway Mobilescope
ClassificationBronchoscope (flexible Or Rigid)
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentSheri L. Musgnung
Olympus Corporation Of The America 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-15
Decision Date2021-01-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170318320 K201300 000
04953170144011 K201300 000
04953170054372 K201300 000
04953170407260 K201300 000
04953170407208 K201300 000
04953170407147 K201300 000
04953170071386 K201300 000
04953170437953 K201300 000

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