FDA 510(k)

OPTI® B-Lac Cassette

Номер K: K200986 · 2021-08-02

Дата решения2021-08-02

Код продуктаCHL

Консультативный комитетCH

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: CHL)

K252207ABL90 FLEX PLUS Система, safeCLINITUBESRadiometer Medicals Aps K244014i-STAT CG4+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K240998ABL90 FLEX PLUS СистемаRadiometer Medicals Aps K230285i-STAT CG8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K221900Stat Profile Prime Plus Analyzer SystemNova Biomedical Corporation K223857i-STAT G3+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.

Официальный источник

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