Model 43100A Series Defibrillator, Modification
by Hewlett-Packard Co. 510(k)
Active
510(k) K910754
Overview
The Model 43100A Series Defibrillator, Modification is a low-energy DC defibrillator that includes paddles. It is a cardiovascular device designed to deliver controlled electrical shocks to the heart.
This device is manufactured by Hewlett-Packard Co. and is supplied as a modification to the existing model. It is a Class II device with FDA 510(k) clearance (K910754) and is regulated under product code LDD. The device is intended for use in cardiovascular settings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910754 | Date8 May 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LDD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5300
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent