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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 K213760
Device Name ABMD Software
Applicant
HeartLung Corporation
1124 W Carson St.
Torrance,  CA  90502
Applicant Contact Morteza Naghavi
Correspondent
HeartLung Corporation
1124 W Carson St.
Torrance,  CA  90502
Correspondent Contact Lauren Lee
Regulation Number892.1170
Classification Product Code
KGI  
Date Received12/01/2021
Decision Date 07/29/2022
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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