EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
FDA 510(k) clearance K092913 · decided 2009-10-16
Clearance details
- K-number
- K092913
- Device name
- EP-4TM CARDIAC STIMULATOR, MODELS: EP-04-02, EP-04-04
- Applicant
- Ep Medsystems
- Decision
- Substantially Equivalent
- Date received
- 2009-09-22
- Decision date
- 2009-10-16
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- JOQ
- Device class
- 2
- Regulation number
- 870.1750
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Berlin, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Bloom2 Programmable Electrophysiology Stimulator (K173439) | Fischer Medical | 2018-03-29 |
| STIMLAB (K072200) | Micropace Pty, Ltd. | 2007-10-26 |
| Z6 STIMULATOR (K070743) | St Cardio Technologies, LLC | 2007-07-02 |
| EP-4 CLINICAL STIMUTATOR (K041442) | Ep Medsystems | 2004-09-14 |
| EP-4 CLINICAL STIMULATOR (K040207) | Ep Medsystems | 2004-02-27 |
| EPS320 CARDIAC STIMULATOR (K011826) | Micropace Pty, Ltd. | 2002-01-24 |
| EPSTIM ELECTROPHYSIOLOGY STIMULATOR CONTROL PROGRAM, BLOOM DTU-215 ELECTROPHYSIOLOGY PROGRAMMABLE STIMULATOR (K991293) | Fischer Medical Technologies, Inc. | 2000-05-05 |
| PACE-1A CARDIAC STIMULATOR (K963579) | Radionics, Inc. | 1996-11-08 |
| EP MEDICAL, INC. EP-3 CLINICAL STIMULATOR (K935590) | Ep Medical, Inc. | 1994-05-05 |
| CONSTANT CURRENT STIMULATOR MODEL 022101 (K900553) | Ep Technologies, Inc. | 1990-03-13 |
| HB 1000, BRUGADA ELECTROPHYSIOLOGY SYSTEM (K893094) | Heartware Intl. Corp. | 1989-10-02 |
| MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR (K861368) | Medtronic Vascular | 1986-08-04 |
Recalls involving this device
No recalls on record reference this clearance.