Model 43420B Newwave Holter System/Modification
by Hewlett-Packard Co. 510(k)
Active
510(k) K910291
Overview
The device is a Detector and Alarm, Arrhythmia, classified under product code DSI and regulation number 870.1025. It is a Holter system designed for cardiovascular monitoring and arrhythmia detection.
It was submitted by Hewlett-Packard Co. and received FDA 510(k) clearance K910291 on April 22, 1991, following a traditional review process. The device is classified as Class II with special controls and was deemed substantially equivalent to a predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910291 | Date22 Apr 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- Withdrawn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
- DSI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Hewlett-Packard Co.
Questions
What is the MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION used for?
This device is a Holter system designed for cardiovascular monitoring and arrhythmia detection, specifically functioning as a detector and alarm for arrhythmias, as indicated by its product code DSI and regulation number 870.1025.
How was the MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION regulated and cleared?
It received FDA 510(k) clearance under number K910291 on April 22, 1991, following a traditional review process, and was deemed substantially equivalent to a predicate device, classified as Class II with special controls.
Who manufactured the MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION and where was it submitted from?
The device was manufactured by Hewlett-Packard Co. and submitted from their address at 1700 S. Baker St., Mcminnville, OR 97128, United States.