The following data is part of a premarket notification filed by Ep Medsystems with the FDA for Ep-4tm Cardiac Stimulator, Models: Ep-04-02, Ep-04-04.
| Device ID | K092913 |
| 510k Number | K092913 |
| Device Name: | EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04 |
| Classification | Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) |
| Applicant | EP MEDSYSTEMS 575 RT. 73 NORTH, BLDG. D West Berlin, NJ 08091 |
| Contact | Sushma Rao |
| Correspondent | Sushma Rao EP MEDSYSTEMS 575 RT. 73 NORTH, BLDG. D West Berlin, NJ 08091 |
| Product Code | JOQ |
| CFR Regulation Number | 870.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2009-10-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05415067018076 | K092913 | 000 |
| 05415067018069 | K092913 | 000 |
| 05414734219112 | K092913 | 000 |
| 05414734208758 | K092913 | 000 |
| 05414734208741 | K092913 | 000 |
| 05414734030236 | K092913 | 000 |