The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 3000.
| Device ID | K992834 |
| 510k Number | K992834 |
| Device Name: | GEM PREMIER 3000 |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | GKF |
| Subsequent Product Code | JFO |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-23 |
| Decision Date | 1999-11-24 |
| Summary: | summary |