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FDA 510(k)

inHEART MODELS

K-Number: K220727 · 2022-05-10

ApplicantInheart, Sas
Decision Date2022-05-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

inHEART MODELS is a medical device manufactured by Inheart, Sas. It received FDA 510(k) clearance on 2022-05-10 under approval number K220727. The device is classified under product code LLZ. 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 2022-05-10. It is manufactured by Inheart, Sas. The 510(k) number is K220727.

When was inHEART MODELS approved by the FDA?

inHEART MODELS received FDA 510(k) clearance on 2022-05-10, under approval number K220727.

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 LLZ.

Other Devices by Inheart, Sas

K231683inHEART Models

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Official Source

View on FDA Database →

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

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