B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM

System, Imaging, Pulsed Echo, Ultrasonic

BIOVISION, INC.

The following data is part of a premarket notification filed by Biovision, Inc. with the FDA for B-scan Opthalmic Ultrasound Imaging System.

Pre-market Notification Details

Device IDK926251
510k NumberK926251
Device Name:B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant BIOVISION, INC. B.P. 11 63114 COUDES France,  FR
ContactWilliam D Sterling
CorrespondentWilliam D Sterling
BIOVISION, INC. B.P. 11 63114 COUDES France,  FR
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-14
Decision Date1993-09-14

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