The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 5000.
| Device ID | K173403 |
| 510k Number | K173403 |
| Device Name: | GEM Premier 5000 |
| 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 | CGZ |
| Subsequent Product Code | GKF |
| Subsequent Product Code | GKR |
| Subsequent Product Code | GLY |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-31 |
| Decision Date | 2017-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950899662 | K173403 | 000 |
| 08426950807674 | K173403 | 000 |
| 08426950807667 | K173403 | 000 |
| 08426950807650 | K173403 | 000 |
| 08426950807643 | K173403 | 000 |
| 08426950807636 | K173403 | 000 |
| 08426950807629 | K173403 | 000 |
| 08426950807612 | K173403 | 000 |
| 08426950807605 | K173403 | 000 |
| 08426950807599 | K173403 | 000 |
| 08426950807582 | K173403 | 000 |
| 08426950807575 | K173403 | 000 |
| 08426950807568 | K173403 | 000 |
| 08426950807544 | K173403 | 000 |
| 08426950807681 | K173403 | 000 |
| 08426950807698 | K173403 | 000 |
| 08426950807827 | K173403 | 000 |
| 08426950807810 | K173403 | 000 |
| 08426950807803 | K173403 | 000 |
| 08426950807797 | K173403 | 000 |
| 08426950807780 | K173403 | 000 |
| 08426950807773 | K173403 | 000 |
| 08426950807766 | K173403 | 000 |
| 08426950807759 | K173403 | 000 |
| 08426950807742 | K173403 | 000 |
| 08426950807735 | K173403 | 000 |
| 08426950807728 | K173403 | 000 |
| 08426950807711 | K173403 | 000 |
| 08426950807704 | K173403 | 000 |
| 08426950807537 | K173403 | 000 |