FDA 510(k)

STAR Apollo Mapping System

Número K: K220786 · 2022-12-01

Data da decisão2022-12-01

Código do produtoDQK

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

STAR Apollo Mapping System is the device name listed in this FDA 510(k) record. The listed applicant is Rhythm Al, Ltd.. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K220786. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the STAR Apollo Mapping System?

STAR Apollo Mapping System is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Rhythm Al, Ltd.. The 510(k) number is K220786.

When did STAR Apollo Mapping System receive FDA 510(k) clearance?

STAR Apollo Mapping System received FDA 510(k) clearance on 2022-12-01, under 510(k) number K220786.

Who is the listed applicant for STAR Apollo Mapping System?

The FDA 510(k) record lists Rhythm Al, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STAR Apollo Mapping System?

The FDA product code for STAR Apollo Mapping System is DQK.

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