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FDA 510(k)

ABMD Software

K-Number: K213760 · 2022-07-29

ApplicantHeartLung Corporation
Decision Date2022-07-29
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ABMD Software is a medical device manufactured by HeartLung Corporation. It received FDA 510(k) clearance on 2022-07-29 under approval number K213760. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABMD Software?

ABMD Software is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by HeartLung Corporation. The 510(k) number is K213760.

When was ABMD Software approved by the FDA?

ABMD Software received FDA 510(k) clearance on 2022-07-29, under approval number K213760.

What company makes ABMD Software?

ABMD Software is manufactured by HeartLung Corporation.

What is the FDA product code for ABMD Software?

The FDA product code for ABMD Software is KGI.

Other Devices by HeartLung Corporation

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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