The following data is part of a premarket notification filed by Opti Medical Systems Inc. with the FDA for Opti Cca-ts, B-lac Cassette Model Bp7561.
| Device ID | K093280 |
| 510k Number | K093280 |
| Device Name: | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | OPTI MEDICAL SYSTEMS INC. 235 HEMBREE PARK DRIVE Roswell, GA 30076 |
| Contact | Len Owens |
| Correspondent | Len Owens OPTI MEDICAL SYSTEMS INC. 235 HEMBREE PARK DRIVE Roswell, GA 30076 |
| Product Code | CHL |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GLY |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-20 |
| Decision Date | 2011-01-07 |
| Summary: | summary |