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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 K220068
Device Name Butterfly iQ/iQ+ Ultrasound System
Applicant
Butterfly Network, Inc.
530 Old Whitfield Street
Guilford,  CT  06437
Applicant Contact Brian Sawin
Correspondent
Butterfly Network, Inc.
1600 District Ave
Burlington,  MA  01803
Correspondent Contact Lynda Ikejimba
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   IYN   QIH  
Date Received01/10/2022
Decision Date 03/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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