Programmable Stimulator 2352
FDA 510(k) K833421 · Medtronic Vascular
510(k) numberK833421
Submission
- Device name
- Programmable Stimulator 2352
- Applicant
- Medtronic Vascular
Walker, MI, US - Received
- October 3, 1983
- Decision date
- January 30, 1984
- 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
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|---|---|---|---|
| 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 |
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Questions and answers
When was Programmable Stimulator 2352 cleared by the FDA?
Programmable Stimulator 2352 (K833421) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 119 days after the submission was received.
What is the product code of K833421?
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.