The following data is part of a premarket notification filed by Circadian, Inc. with the FDA for Conductance Meter.
Device ID | K833619 |
510k Number | K833619 |
Device Name: | CONDUCTANCE METER |
Classification | Tester, Electrode, Surface, Electrocardiographic |
Applicant | CIRCADIAN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KRC |
CFR Regulation Number | 870.2370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-14 |
Decision Date | 1984-01-27 |