ABMD Software

Densitometer, Bone

HeartLung Corporation

The following data is part of a premarket notification filed by Heartlung Corporation with the FDA for Abmd Software.

Pre-market Notification Details

Device IDK213760
510k NumberK213760
Device Name:ABMD Software
ClassificationDensitometer, Bone
Applicant HeartLung Corporation 1124 W Carson St Torrance,  CA  90502
ContactMorteza Naghavi
CorrespondentLauren Lee
HeartLung Corporation 1124 W Carson St Torrance,  CA  90502
Product CodeKGI  
CFR Regulation Number892.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-01
Decision Date2022-07-29

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