CARECENTER MD— 510(k) K093211

Substantially Equivalent

Cardiac Science Corporation

FDA 510(k) clearance K093211 for CARECENTER MD, Substantially Equivalent on 2010-06-03. Applicant: Cardiac Science Corporation.

Clearance details

Applicant: Cardiac Science Corporation
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 2009-10-13
Decision date: 2010-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.