FDA 510(k)

CarnaLife Holo

K-Number: K221870 · 2023-05-01

Decision Date2023-05-01

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CarnaLife Holo is the device name listed in this FDA 510(k) record. The listed applicant is Medapp S.A.. It received FDA 510(k) clearance on 2023-05-01 under 510(k) number K221870. 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 CarnaLife Holo?

CarnaLife Holo is a medical device that received FDA 510(k) clearance on 2023-05-01. The listed applicant is Medapp S.A.. The 510(k) number is K221870.

When did CarnaLife Holo receive FDA 510(k) clearance?

CarnaLife Holo received FDA 510(k) clearance on 2023-05-01, under 510(k) number K221870.

Who is the listed applicant for CarnaLife Holo?

The FDA 510(k) record lists Medapp S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CarnaLife Holo?

The FDA product code for CarnaLife Holo 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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

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.