ABMD Software

FDA 510(k) K213760 · HeartLung Corporation

Substantially Equivalent

510(k) numberK213760

Submission

Device name
ABMD Software
Applicant
HeartLung Corporation
Torrance, CA, US
Received
December 1, 2021
Decision date
July 29, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KGI – Densitometer, Bone
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1170
Specialty
Radiology

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Questions and answers

When was ABMD Software cleared by the FDA?

ABMD Software (K213760) received a 510(k) decision of Substantially Equivalent on July 29, 2022, 240 days after the submission was received.

What is the product code of K213760?

The FDA product code is KGI – Densitometer, Bone, a Class II (moderate risk) device regulated under 21 CFR 892.1170.