AUTOPULSE RESUSCITATION SYSTEM, MODEL 100— 510(k) K040453
Substantially EquivalentRevivant Corp.
FDA 510(k) clearance K040453 for AUTOPULSE RESUSCITATION SYSTEM, MODEL 100, Substantially Equivalent on 2004-03-11. Applicant: Revivant Corp.. Device class: 2.
Clearance details
- Applicant
- Revivant Corp.
- Product code
- Code DRM
- Device class
- Class 2
- Regulation
- 21 CFR 870.5200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sunnyvale, CA, US
Recent devices under product code DRM
view allMore clearances from Revivant Corp.
view allAdverse events under product code DRM
product code DRM- Death
- 82
- Injury
- 126
- Malfunction
- 4,539
- Total
- 4,747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K040453
K-number listed on FDA's recall record- Z-2090-2014 — 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 compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.
- Z-0658-2013 — 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 adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040453.
Data sourced from openFDA. This site is unofficial and independent of the FDA.