The following data is part of a premarket notification filed by Medisense, Inc. with the FDA for Satellite C Blood Cholesterol Monitoring System.
Device ID | K896467 |
510k Number | K896467 |
Device Name: | SATELLITE C BLOOD CHOLESTEROL MONITORING SYSTEM |
Classification | Enzymatic Esterase--oxidase, Cholesterol |
Applicant | MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
Contact | Lias, Phd |
Correspondent | Lias, Phd MEDISENSE, INC. 128 SIDNEY ST. Cambridge, MA 02139 |
Product Code | CHH |
CFR Regulation Number | 862.1175 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-13 |
Decision Date | 1990-06-12 |