K093280 is an FDA 510(k) clearance for the OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561. This device is classified as a Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (Class II - Special Controls, product code CHL).
Submitted by Opti Medical Systems, Inc. (Roswell, US). The FDA issued a Cleared decision on January 7, 2011, 444 days after receiving the submission on October 20, 2009.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1120.
| 510(k) Number | K093280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 20, 2009 |
| Decision Date | January 07, 2011 |
| Days to Decision | 444 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CHL - Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1120 |