Pulse Generator 696, 696B & 696l
510(k) K841232
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841232 | Date3 Dec 1984 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
This device is an Implantable Pacemaker Pulse-Generator, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. It serves as the control unit for pacing systems, ensuring consistent and programmable stimulation of the heart chambers to maintain proper cardiac function.
The Pulse Generator 696, 696B, and 696L are intended for use in clinical settings by trained medical professionals. These devices are classified as Class III under FDA regulations and are supplied sterile for single-use implantation. They are regulated under the FDA’s 510(k) pathway with a Traditional clearance, filed under the Cardiovascular advisory committee. Each model is identified by its unique reference code and adheres to the regulatory requirements outlined in 21 CFR 870.3610.