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FDA 510(k)

inHEART Models

K-Number: K231683 · 2024-02-29

ApplicantInheart, Sas
Decision Date2024-02-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

inHEART Models is a medical device manufactured by Inheart, Sas. It received FDA 510(k) clearance on 2024-02-29 under approval number K231683. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the inHEART Models?

inHEART Models is a medical device that received FDA 510(k) clearance on 2024-02-29. It is manufactured by Inheart, Sas. The 510(k) number is K231683.

When was inHEART Models approved by the FDA?

inHEART Models received FDA 510(k) clearance on 2024-02-29, under approval number K231683.

What company makes inHEART Models?

inHEART Models is manufactured by Inheart, Sas.

What is the FDA product code for inHEART Models?

The FDA product code for inHEART Models is QIH.

Other Devices by Inheart, Sas

Related Devices (Code: QIH)

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.