FDA 510(k)

OPTI® B-Lac Cassette

Número K: K200986 · 2021-08-02

Data da decisão2021-08-02

Código do produtoCHL

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

OPTI® B-Lac Cassette is the device name listed in this FDA 510(k) record. The listed applicant is Opti Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-08-02 under 510(k) number K200986. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the OPTI® B-Lac Cassette?

OPTI® B-Lac Cassette is a medical device that received FDA 510(k) clearance on 2021-08-02. The listed applicant is Opti Medical Systems, Inc.. The 510(k) number is K200986.

When did OPTI® B-Lac Cassette receive FDA 510(k) clearance?

OPTI® B-Lac Cassette received FDA 510(k) clearance on 2021-08-02, under 510(k) number K200986.

Who is the listed applicant for OPTI® B-Lac Cassette?

The FDA 510(k) record lists Opti Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTI® B-Lac Cassette?

The FDA product code for OPTI® B-Lac Cassette is CHL.

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Fonte oficial

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