OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)

Transducer, Ultrasonic, Diagnostic

OLYMPUS AMERICA, INC.

The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Ultrasonic Probe For Esophogus (mh-908).

Pre-market Notification Details

Device IDK952892
510k NumberK952892
Device Name:OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908)
ClassificationTransducer, Ultrasonic, Diagnostic
Applicant OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
ContactBarry E Sands
CorrespondentBarry E Sands
OLYMPUS AMERICA, INC. TWO CORPORATE CENTER DR. Melville,  NY  11747 -3157
Product CodeITX  
CFR Regulation Number892.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-23
Decision Date1996-02-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170360435 K952892 000
04953170055553 K952892 000
04953170055560 K952892 000
04953170055577 K952892 000
04953170055591 K952892 000
14953170058858 K952892 000
04953170064692 K952892 000
04953170064883 K952892 000
04953170355691 K952892 000
04953170355707 K952892 000
04953170355745 K952892 000
04953170355752 K952892 000
04953170356063 K952892 000
04953170356186 K952892 000
04953170055546 K952892 000

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