Circamed Monitor Remote Start Conductance Meter
510(k) K874155
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874155 | Date23 Nov 1987 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2370
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Circamed Monitor Remote Start Conductance Meter is a Tester, Electrode, Surface, Electrocardiographic device. It is classified as a class 2 device and is used in the medical specialty of Cardiovascular. The device is substantially equivalent to other devices on the market.
The device is supplied with a product code of KRC and is regulated under regulation number 870.2370. It has been assigned a K number of K874155 and has been cleared through the traditional clearance type. The device is intended for use in a cardiovascular setting and is a single device, not a system or kit.
Other devices from Circadian, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the Circamed Monitor Remote Start Conductance Meter used for?
The device is intended for use in a cardiovascular setting, specifically for electrocardiographic purposes.
Is the Circamed Monitor Remote Start Conductance Meter a single-use device?
The device is described as a single device, not a system or kit, but its reuse or single-use status is not explicitly stated.
What regulatory pathway was used for the Circamed Monitor Remote Start Conductance Meter?
The device was cleared through the traditional clearance type, with a K number of K874155, under regulation number 870.2370.