MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100— 510(k) K032852

Substantially Equivalent

Revivant Corp.

FDA 510(k) clearance K032852 for MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100, Substantially Equivalent on 2003-11-12. Applicant: Revivant Corp..

Clearance details

Applicant: Revivant Corp.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2003-09-12
Decision date: 2003-11-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Sunnyvale, CA, US

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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.