Ep-4TM Cardiac Stimulator, Models: Ep-04-02, Ep-04-04
510(k) K092913
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK092913 | Date16 Oct 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 10 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1750
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent