Chronocor V External Pacer, Model 297A
by Seamed Corp. 510(k)
Active
510(k) K850822
Overview
The Chronocor V External Pacer, Model 297A is a Pulse-Generator, Pacemaker, External device classified as a Class 2 Cardiovascular device. It is intended to provide temporary pacing support for patients with cardiac rhythm disorders.
The device is supplied as a single-use external pacemaker and is not reusable. It is intended for use in clinical settings under the supervision of trained healthcare professionals. The device is not MRI safe and requires proper storage conditions as per manufacturer guidelines. The device has received FDA 510(k) clearance (K850822) under the Traditional pathway.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850822 | Date16 Jul 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3600
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent