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FDA 510(k)

Jazz

K-Number: K223659 · 2023-09-22

ApplicantAi Medical AG
Decision Date2023-09-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Jazz is a medical device manufactured by Ai Medical AG. It received FDA 510(k) clearance on 2023-09-22 under approval number K223659. 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 Jazz?

Jazz is a medical device that received FDA 510(k) clearance on 2023-09-22. It is manufactured by Ai Medical AG. The 510(k) number is K223659.

When was Jazz approved by the FDA?

Jazz received FDA 510(k) clearance on 2023-09-22, under approval number K223659.

What company makes Jazz?

Jazz is manufactured by Ai Medical AG.

What is the FDA product code for Jazz?

The FDA product code for Jazz is LLZ.

Related Devices (Code: LLZ)

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.