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 |