The following data is part of a premarket notification filed by Osmetech, Inc. with the FDA for Osmetech Opti R Critical Care Analyzer, Model Gd7044.
| Device ID | K061730 |
| 510k Number | K061730 |
| Device Name: | OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044 |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | OSMETECH, INC. 235 HEMBREE PARK DRIVE Roswell, GA 30076 |
| Contact | Bernie Heitz |
| Correspondent | Bernie Heitz OSMETECH, INC. 235 HEMBREE PARK DRIVE Roswell, GA 30076 |
| Product Code | CEM |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GLY |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-20 |
| Decision Date | 2006-08-04 |
| Summary: | summary |