The following data is part of a premarket notification filed by Mallinckrodt Sensor Systems, Inc. with the FDA for Gem-premier System.
| Device ID | K910305 |
| 510k Number | K910305 |
| Device Name: | GEM-PREMIER SYSTEM |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | MALLINCKRODT SENSOR SYSTEMS, INC. 1230 EISENHOWER PLACE Ann Arbor, MI 48108 |
| Contact | Bruce M Burgess |
| Correspondent | Bruce M Burgess MALLINCKRODT SENSOR SYSTEMS, INC. 1230 EISENHOWER PLACE Ann Arbor, MI 48108 |
| Product Code | JGS |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-24 |
| Decision Date | 1991-04-03 |