The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Satellite K+ Blood Potassium Monitoring System.
Device ID | K897110 |
510k Number | K897110 |
Device Name: | SATELLITE K+ BLOOD POTASSIUM MONITORING SYSTEM |
Classification | Electrode, Ion Specific, Potassium |
Applicant | MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
Contact | Lias, Ph.d. |
Correspondent | Lias, Ph.d. MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
Product Code | CEM |
CFR Regulation Number | 862.1600 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-26 |
Decision Date | 1990-02-27 |