AutoPulse NXT Resuscitation System— 510(k) K221700

Substantially Equivalent

Zoll Circulation, Inc.

FDA 510(k) clearance K221700 for AutoPulse NXT Resuscitation System, Substantially Equivalent on 2023-03-09. Applicant: Zoll Circulation, Inc..

Clearance details

Applicant: Zoll Circulation, Inc.
Product code: Code DRM
Advisory panel: Cardiovascular
Date received: 2022-06-13
Decision date: 2023-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, 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.