CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES— 510(k) K101576

Substantially Equivalent

Team Innovations, Inc.

FDA 510(k) clearance K101576 for CENTERRIDGE DIAGNOSTIC ECG ELECTRODE, CENTERRIDGE MONITORING ECG ELECTRODES, Substantially Equivalent on 2010-07-22. Applicant: Team Innovations, Inc..

Clearance details

Applicant: Team Innovations, Inc.
Product code: Code DRX
Advisory panel: Cardiovascular
Date received: 2010-06-07
Decision date: 2010-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Allis, WI, US

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Adverse events under product code DRX

product code DRX

Death: 6
Injury: 476
Other: 2
Total: 484

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.