EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04
FDA 510(k) K092913 · Ep Medsystems
510(k) numberK092913
Submission
- Device name
- EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04
- Applicant
- Ep Medsystems
West Berlin, NJ, US - Received
- September 22, 2009
- Decision date
- October 16, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOQ – Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1750
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code JOQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K173439 | Bloom2 Programmable Electrophysiology StimulatorJOQ · Traditional | Fischer Medical | 03/29/2018SE |
| K072200 | StimlabJOQ · Traditional | Micropace Pty, Ltd. | 10/26/2007SE |
| K070743 | Z6 StimulatorJOQ · Traditional | St Cardio Technologies, LLC | 07/02/2007SE |
| K041442 | EP-4 Clinical StimutatorJOQ · Special | Ep Medsystems | 09/14/2004SE |
| K040207 | EP-4 Clinical StimulatorJOQ · Special | Ep Medsystems | 02/27/2004SE |
| K011826 | EPS320 Cardiac StimulatorJOQ · Traditional | Micropace Pty, Ltd. | 01/24/2002SE |
| K991293 | Epstim Electrophysiology Stimulator Control Program, Bloom DTU-215 Electrophysiology…JOQ · Traditional | Fischer Medical Technologies, Inc. | 05/05/2000SE |
| K963579 | PACE-1A Cardiac StimulatorJOQ · Traditional | Radionics, Inc. | 11/08/1996SE |
| K935590 | Ep Medical, Inc. EP-3 Clinical StimulatorJOQ · Traditional | Ep Medical, Inc. | 05/05/1994SE |
| K900553 | Constant Current Stimulator Model 022101JOQ · Traditional | Ep Technologies, Inc. | 03/13/1990SE |
More from Ep Technologies, Inc.
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|---|---|---|
| K073709 | Modification to Viewmate SystemIYN · Special | 03/11/2008SE |
| K071028 | Viewmate SystemITN · Special | 05/01/2007SE |
| K070706 | Ep-WorkmateDQK · Special | 04/11/2007SE |
| K063277 | MapmateDQK · Special | 11/30/2006SE |
| K063113 | Ep-WorkmateDQK · Special | 10/27/2006SE |
| K041442 | EP-4 Clinical StimutatorJOQ · Special | 09/14/2004SE |
| K033963 | Ep Deflectable CathetersDRF · Special | 04/15/2004SE |
| K040207 | EP-4 Clinical StimulatorJOQ · Special | 02/27/2004SE |
| K031066 | Viewmate Ultrasound Imaging SystemIYN · Traditional | 10/17/2003SE |
| K032225 | Ep-Workmate with RPM SystemDQK · Special | 08/20/2003SE |
Questions and answers
When was EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04 cleared by the FDA?
EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04 (K092913) received a 510(k) decision of Substantially Equivalent on October 16, 2009, 24 days after the submission was received.
What is the product code of K092913?
The FDA product code is JOQ – Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only), a Class II (moderate risk) device regulated under 21 CFR 870.1750.