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FDA 510(k)

OPTI CCA-TS2

K-Number: K131126 · 2013-08-22

ApplicantOpti Medical Systems, Inc.
Decision Date2013-08-22
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OPTI CCA-TS2 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 2013-08-22 under 510(k) number K131126. 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 CCA-TS2?

OPTI CCA-TS2 is a medical device that received FDA 510(k) clearance on 2013-08-22. The listed applicant is Opti Medical Systems, Inc.. The 510(k) number is K131126.

When did OPTI CCA-TS2 receive FDA 510(k) clearance?

OPTI CCA-TS2 received FDA 510(k) clearance on 2013-08-22, under 510(k) number K131126.

Who is the listed applicant for OPTI CCA-TS2?

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 CCA-TS2?

The FDA product code for OPTI CCA-TS2 is CHL.

Other records listing Opti Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200986OPTI® B-Lac CassetteK093280OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561

Related Devices (Code: 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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