Uroflowmeter

Uroflowmeter

BE TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Be Technologies, Inc. with the FDA for Uroflowmeter.

Pre-market Notification Details

Device IDK142425
510k NumberK142425
Device Name:Uroflowmeter
ClassificationUroflowmeter
Applicant BE TECHNOLOGIES, INC. 2939 20th Avenue San Francisco,  CA  94132
ContactEdward Belotserkovsky
CorrespondentAngela Mallery
NAMSA 4050 Olson Memorial Highway, Suite 450 Minneapolis,  MN  55442
Product CodeEXY  
CFR Regulation Number876.1800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-08-29
Decision Date2014-10-27
Summary:summary

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