FDA 510(k)

Medical Gas Analyzer (AG200)

Número K: K250148 · 2025-08-28

RequerentePrior Care Science Technology, Ltd.

Data da decisão2025-08-28

Código do produtoCCK

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Gas Analyzer (AG200) is the device name listed in this FDA 510(k) record. The listed applicant is Prior Care Science Technology, Ltd.. It received FDA 510(k) clearance on 2025-08-28 under 510(k) number K250148. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medical Gas Analyzer (AG200)?

Medical Gas Analyzer (AG200) is a medical device that received FDA 510(k) clearance on 2025-08-28. The listed applicant is Prior Care Science Technology, Ltd.. The 510(k) number is K250148.

When did Medical Gas Analyzer (AG200) receive FDA 510(k) clearance?

Medical Gas Analyzer (AG200) received FDA 510(k) clearance on 2025-08-28, under 510(k) number K250148.

Who is the listed applicant for Medical Gas Analyzer (AG200)?

The FDA 510(k) record lists Prior Care Science Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Gas Analyzer (AG200)?

The FDA product code for Medical Gas Analyzer (AG200) is CCK.

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Fonte oficial

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