Auto 3D Bladder Volume Tool

System, Imaging, Pulsed Echo, Ultrasonic

Butterfly Network, Inc.

The following data is part of a premarket notification filed by Butterfly Network, Inc. with the FDA for Auto 3d Bladder Volume Tool.

Pre-market Notification Details

Device IDK200980
510k NumberK200980
Device Name:Auto 3D Bladder Volume Tool
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant Butterfly Network, Inc. 530 Old Whitfield Street Guilford,  CT  06437
ContactBrian Sawin
CorrespondentBrian Sawin
Butterfly Network, Inc. 530 Old Whitfield Street Guilford,  CT  06437
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-14
Decision Date2020-06-11

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