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FDA 510(k)

OPTI® B-Lac Cassette

K-Number: K200986 · 2021-08-02

ApplicantOpti Medical Systems, Inc.
Decision Date2021-08-02
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Opti Medical Systems, Inc.. The 510(k) number is K200986.

When was OPTI® B-Lac Cassette approved by the FDA?

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

What company makes OPTI® B-Lac Cassette?

OPTI® B-Lac Cassette is manufactured by Opti Medical Systems, Inc..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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