FDA 510(k)

SynthVISION 1.0.0

Número K: K240724 · 2024-08-08

RequerenteSynthesis Health Intelligence, Inc.

Data da decisão2024-08-08

Código do produtoLLZ

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

SynthVISION 1.0.0 is the device name listed in this FDA 510(k) record. The listed applicant is Synthesis Health Intelligence, Inc.. It received FDA 510(k) clearance on 2024-08-08 under 510(k) number K240724. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SynthVISION 1.0.0?

SynthVISION 1.0.0 is a medical device that received FDA 510(k) clearance on 2024-08-08. The listed applicant is Synthesis Health Intelligence, Inc.. The 510(k) number is K240724.

When did SynthVISION 1.0.0 receive FDA 510(k) clearance?

SynthVISION 1.0.0 received FDA 510(k) clearance on 2024-08-08, under 510(k) number K240724.

Who is the listed applicant for SynthVISION 1.0.0?

The FDA 510(k) record lists Synthesis Health Intelligence, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SynthVISION 1.0.0?

The FDA product code for SynthVISION 1.0.0 is LLZ.

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