AUTOPULSE RESUSCITATION SYSTEM— 510(k) K022345

Substantially Equivalent

Revivant Corp.

FDA 510(k) clearance K022345 for AUTOPULSE RESUSCITATION SYSTEM, Substantially Equivalent on 2002-08-15. Applicant: Revivant Corp..

Clearance details

Applicant: Revivant Corp.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2002-07-19
Decision date: 2002-08-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.