The following data is part of a premarket notification filed by Mallinckrodt Sensor Systems, Inc. with the FDA for Gem Premier Plus Model 5500.
| Device ID | K961335 |
| 510k Number | K961335 |
| Device Name: | GEM PREMIER PLUS MODEL 5500 |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | MALLINCKRODT SENSOR SYSTEMS, INC. 1590 EISENHOWER PL. Ann Arbor, MI 48108 |
| Contact | Andrew C Taylor |
| Correspondent | Andrew C Taylor MALLINCKRODT SENSOR SYSTEMS, INC. 1590 EISENHOWER PL. Ann Arbor, MI 48108 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | GKF |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-06-28 |
| Summary: | summary |