The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Gem Premier 5000.
Device ID | K203790 |
510k Number | K203790 |
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 | Gabriella Erdosy |
Correspondent | Gabriella Erdosy 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 | 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 | 2020-12-28 |
Decision Date | 2021-08-20 |