The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 4000.
| Device ID | K133407 |
| 510k Number | K133407 |
| Device Name: | GEM PREMIER 4000 |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIG |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKF |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GLY |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KHP |
| Subsequent Product Code | MQM |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-06 |
| Decision Date | 2014-01-13 |
| Summary: | summary |