AUTOPULSE RESUSCITATION SYSTEM MODEL100— 510(k) K063602

Substantially Equivalent

Zoll Circulation

FDA 510(k) clearance K063602 for AUTOPULSE RESUSCITATION SYSTEM MODEL100, Substantially Equivalent on 2006-12-21. Applicant: Zoll Circulation.

Clearance details

Applicant: Zoll Circulation
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2006-12-04
Decision date: 2006-12-21
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.