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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 doppler, ultrasonic
510(k) Number K163510
Device Name Poseidon Ultrasound System
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 Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received12/15/2016
Decision Date 09/06/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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