BLADDERSCAN BVI 5000

System, Imaging, Pulsed Echo, Ultrasonic

DIAGNOSTIC ULTRASOUND CORP.

The following data is part of a premarket notification filed by Diagnostic Ultrasound Corp. with the FDA for Bladderscan Bvi 5000.

Pre-market Notification Details

Device IDK955942
510k NumberK955942
Device Name:BLADDERSCAN BVI 5000
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant DIAGNOSTIC ULTRASOUND CORP. 18109 NE 76TH ST. Redmond,  WA  98052
ContactGerald Mcmorrow
CorrespondentGerald Mcmorrow
DIAGNOSTIC ULTRASOUND CORP. 18109 NE 76TH ST. Redmond,  WA  98052
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-03-15
Summary:summary

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