Breast Volume Navigator (BVN) Model G-2000

System, Imaging, Pulsed Echo, Ultrasonic

MetriTrack, Inc.

The following data is part of a premarket notification filed by Metritrack, Inc. with the FDA for Breast Volume Navigator (bvn) Model G-2000.

Pre-market Notification Details

Device IDK211098
510k NumberK211098
Device Name:Breast Volume Navigator (BVN) Model G-2000
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant MetriTrack, Inc. 4415 W. Harrison Street Suite 243 Hillside,  IL  60162
ContactMirela Wohlford
CorrespondentPrithul Bom
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedYes
Combination ProductNo
Date Received2021-04-13
Decision Date2021-05-26


Device IdentifiersubmissionNumberSupplement
08636860003008 K211098 000

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