External Test Pulse Generator
FDA 510(k) K780717 · Vitatron Medical BV
510(k) numberK780717
Submission
- Device name
- External Test Pulse Generator
- Applicant
- Vitatron Medical BV
Walker, MI, US - Received
- April 27, 1978
- Decision date
- June 30, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTC – Analyzer, Pacemaker Generator Function
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3630
- Specialty
- Cardiovascular
Other 510(k)s with product code DTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170815 | PSA CableDTC · Traditional | Boston Scientific Corporation | 07/06/2017SE |
| K083674 | PK-141 Patient CableDTC · Traditional | Biotronik, Inc. | 04/01/2009SE |
| K011729 | Sigma Pace External Pacemaker Analyzer Model #1000DTC · Traditional | Dni Nevada, Inc. | 08/30/2001SE |
| K002497 | Model 4810 Analyzer Output AdapterDTC · Traditional | Pace Medical | 10/10/2000SE |
| K961582 | External Pacemaker Analyzer, Model PMT 100DTC · Traditional | North American Technical Services Corp. | 11/08/1996SE |
| K903966 | External Pacemaker Analyzer Model PMA-1DTC · Traditional | Bio-Tek Instruments, Inc. | 06/19/1991SE |
| K910595 | Model 5311B A-V Pacing System AnalyzerDTC · Traditional | Medtronic Vascular | 05/07/1991SE |
| K910223 | Cpi Model 2215/SEAMED Model 3400DTC · Traditional | Seamed Corp. | 03/19/1991SE |
| K901332 | PK-55 Andover Medical Part #5455 Label ChangeDTC · Traditional | Biotronik, GmbH & Co. | 05/09/1990SE |
| K896632 | Medtronic Model 5401B Test CableDTC · Traditional | Medtronic Vascular | 12/13/1989SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K854790 | Ceryx Pacemaker Models 114, 314 & 614DXY · Traditional | 08/28/1986SE |
| K844484 | Hewlett Packardt HP 85 W/ Vitatron PH1 Program HeaKRG · Traditional | 07/24/1985SE |
| K844485 | CERYX6, 611, Ceryx 3 311 & Ceryx 1 111KRG · Traditional | 04/19/1985SE |
| K844483 | TP 1KRG · Traditional | 04/19/1985SE |
| K840668 | Electrode Pacemaker, Perm & TempDTB · Traditional | 09/24/1984SE |
| K831860 | Generator, Pulse, Pacemaker #532DXY · Traditional | 10/27/1983SE |
| K831859 | Pacemaker Programmer #2032DXY · Traditional | 10/27/1983SE |
| K810928 | Endocardial ElectrodeDTB · Traditional | 07/02/1981SE |
| K791920 | Cardiac Pacemaker P4000 Ser. & P1000DXY · Traditional | 11/29/1979SE |
| K791921 | Cardiac Pacemaker C4000, C1000 Ser.DXY · Traditional | 10/26/1979SE |
Questions and answers
When was External Test Pulse Generator cleared by the FDA?
External Test Pulse Generator (K780717) received a 510(k) decision of Substantially Equivalent on June 30, 1978, 64 days after the submission was received.
What is the product code of K780717?
The FDA product code is DTC – Analyzer, Pacemaker Generator Function, a Class II (moderate risk) device regulated under 21 CFR 870.3630.