Jazz
K-Number: K223659 · 2023-09-22
ApplicantAi Medical AG
Decision Date2023-09-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Jazz is the device name listed in this FDA 510(k) record. The listed applicant is Ai Medical AG. It received FDA 510(k) clearance on 2023-09-22 under 510(k) 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. The listed applicant is Ai Medical AG. The 510(k) number is K223659.
When did Jazz receive FDA 510(k) clearance?
Jazz received FDA 510(k) clearance on 2023-09-22, under 510(k) number K223659.
Who is the listed applicant for Jazz?
The FDA 510(k) record lists Ai Medical AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Jazz?
The FDA product code for Jazz is LLZ.
Related Devices (Code: LLZ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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