External Test Pulse Generator
by Vitatron Medical BV 510(k)
Active
510(k) K780717
Overview
An external test pulse generator is a device used to evaluate the function of pacemaker generators. It is designed to simulate cardiac electrical activity for testing purposes.
This device is supplied non-sterile and is intended for reusable use in clinical or laboratory settings. It is authorized under FDA 510(k) clearance K780717 and classified as a Class II device under regulation number 870.3630.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780717 | Date30 Jun 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3630
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Vitatron Medical BV
Questions
What is the EXTERNAL TEST PULSE GENERATOR used for?
The EXTERNAL TEST PULSE GENERATOR is used to evaluate the function of pacemaker generators by simulating cardiac electrical activity for testing purposes in clinical or laboratory environments.
Is the EXTERNAL TEST PULSE GENERATOR supplied sterile or non-sterile, and is it intended for single-use or reuse?
The device is supplied non-sterile and is intended for reusable use, meaning it can be cleaned and used multiple times in clinical or laboratory settings after appropriate reprocessing.
What regulatory pathway was used for the EXTERNAL TEST PULSE GENERATOR, and what is its classification?
The EXTERNAL TEST PULSE GENERATOR received FDA 510(k) clearance under K780717 and is classified as a Class II medical device under regulation number 870.3630.