Model 535-02 Trace-a-Pace Transmitter
by Intermedics, Inc. 510(k)
Active
510(k) K821726
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821726 | Date8 Jul 1982 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DXH
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.2920
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent