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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Densitometer, Bone
510(k) Number K242295
Device Name BunkerHill BMD
Applicant
BunkerHill Health
436 Bryant Street
San Francisco,  CA  94107
Applicant Contact Nishith Khandwala
Correspondent
BunkerHill Health
436 Bryant Street
San Francisco,  CA  94107
Correspondent Contact Eren Alkan
Regulation Number892.1170
Classification Product Code
KGI  
Date Received08/02/2024
Decision Date 04/08/2025
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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