WIRELESS IMAGE TRANSMITTER UNIT

Laparoscope, General & Plastic Surgery

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Wireless Image Transmitter Unit.

Pre-market Notification Details

Device IDK120278
510k NumberK120278
Device Name:WIRELESS IMAGE TRANSMITTER UNIT
ClassificationLaparoscope, General & Plastic Surgery
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley,  PA  18034 -0610
ContactSheri Musgnung
CorrespondentSheri Musgnung
OLYMPUS MEDICAL SYSTEMS CORP. 3500 CORPORATE PARKWAY P.O. BOX 610 Center Valley,  PA  18034 -0610
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-30
Decision Date2012-08-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170327735 K120278 000
04953170327711 K120278 000
04953170327681 K120278 000

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