Constant Current Stimulator Model 022101
FDA 510(k) K900553 · Ep Technologies, Inc.
510(k) numberK900553
Submission
- Device name
- Constant Current Stimulator Model 022101
- Applicant
- Ep Technologies, Inc.
Mountain View, CA, US - Received
- February 6, 1990
- Decision date
- March 13, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K092913 | EP-4TM Cardiac Stimulator, Models: EP-04-02, EP-04-04JOQ · Special | Ep Medsystems | 10/16/2009SE |
| 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 |
More from Ep Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043257 | Real-Time Position Management (RPM) SystemDRF · Special | 02/03/2005SE |
| K013349 | Astronomer Plus SystemDQK · Abbreviated | 04/09/2002SE |
| K003452 | Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006DDRF · Special | 12/07/2000SE |
| K940167 | Diagnostic I CatheterDRF · Traditional | 08/02/1994SE |
| K940168 | Diagnostic II CatheterDRF · Traditional | 07/27/1994SE |
| K924109 | Steerocath IIDRF · Traditional | 12/16/1993SE |
| K924108 | Tracfinder IIDRF · Traditional | 12/16/1993SE |
| K913375 | Torque Tube Steerocath(Tm)DRF · Traditional | 10/25/1991SE |
| K903880 | Franz(Tm) Steerable Combination CatheterDRF · Traditional | 10/12/1990SE |
| K900765 | Steerocath(Tm)DRF · Traditional | 05/07/1990SE |
Questions and answers
When was Constant Current Stimulator Model 022101 cleared by the FDA?
Constant Current Stimulator Model 022101 (K900553) received a 510(k) decision of Substantially Equivalent on March 13, 1990, 35 days after the submission was received.
What is the product code of K900553?
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.