Cariel F12
by Odam
510(k) K823934
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823934 | Date16 Dec 1983 | 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- Withdrawn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
- DYC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2400
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 23 Sep 2026
The Cariel F12 is a Vectorcardiograph, a device used in the Cardiovascular medical specialty. It is classified as a class 2 device. The device is used to record and display the electrical activity of the heart.
The Cariel F12 is supplied with a product code of DYC and a regulation number of 870.2400. It has been assigned a k number of K823934 and has received FDA 510K authorization. The device is manufactured by Odam, with registration numbers 3004215117, 1412854, and 3003971136.
Other devices from Odam
Questions
AI-generated answers, 23 Sep 2026
What is the Cariel F12 used for?
The Cariel F12 is used to record and display the electrical activity of the heart, providing valuable information for cardiovascular medical specialty applications.
How is the Cariel F12 supplied?
The Cariel F12 is supplied with a product code of DYC and a regulation number of 870.2400, and has been assigned a k number of K823934.
What is the device classification of the Cariel F12?
The Cariel F12 is classified as a class 2 device, and has received FDA 510K authorization as a substantially equivalent device.