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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 K252148
Device Name Butterfly Gestational Age Tool
Applicant
Butterfly Network, Inc.
1600 District Ave.
Burlington,  MA  01803
Applicant Contact Nathan Sabich
Correspondent
Butterfly Network, Inc.
1600 District Ave.
Burlington,  MA  01803
Correspondent Contact Nathan Sabich
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO   QIH  
Date Received07/09/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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