The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Circamed Monitor Remote Start Conductance Meter.
Device ID | K874155 |
510k Number | K874155 |
Device Name: | CIRCAMED MONITOR REMOTE START CONDUCTANCE METER |
Classification | Tester, Electrode, Surface, Electrocardiographic |
Applicant | CIRCADIAN, INC. 3942 NORTH FIRST ST. San Jose, CA 95134 -1501 |
Contact | Matt S Magoun |
Correspondent | Matt S Magoun CIRCADIAN, INC. 3942 NORTH FIRST ST. San Jose, CA 95134 -1501 |
Product Code | KRC |
CFR Regulation Number | 870.2370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-10-13 |
Decision Date | 1987-11-23 |