Opti CCA-TS2

FDA 510(k) K131126 · Opti Medical Systems, Inc.

Substantially Equivalent

510(k) numberK131126

Submission

Device name
Opti CCA-TS2
Applicant
Opti Medical Systems, Inc.
Roswell, GA, US
Received
April 22, 2013
Decision date
August 22, 2013
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1120
Specialty
Clinical Chemistry

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Questions and answers

When was Opti CCA-TS2 cleared by the FDA?

Opti CCA-TS2 (K131126) received a 510(k) decision of Substantially Equivalent on August 22, 2013, 122 days after the submission was received.

What is the product code of K131126?

The FDA product code is CHL – Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, a Class II (moderate risk) device regulated under 21 CFR 862.1120.