510(k) K032852 ยท DRM Compressor, Cardiac, External
MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
| Applicant | Revivant Corp., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 12, 2003 |
| Received | Sep 12, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032852
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 22, 2014 | Zoll Circulation, Inc. Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery.
The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a Terminated |
DRM | None listed |
| Jan 9, 2013 | Zoll Circulation, Inc. AutoPulse Resuscitation System Model 100,
Mfg by:Zoll Circulation
Sunnyvale, CA.
The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on Terminated |
DRM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.