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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K200980
Device Name Auto 3D Bladder Volume Tool
Applicant
Butterfly Network, Inc.
530 Old Whitfield Street
Guilford,  CT  06437
Applicant Contact Brian Sawin
Correspondent
Butterfly Network, Inc.
530 Old Whitfield Street
Guilford,  CT  06437
Correspondent Contact Brian Sawin
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received04/14/2020
Decision Date 06/11/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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