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

Name: FDA 510(k) clearance K101576
Creator: U.S. Food and Drug Administration
Published: 2010-07-22

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.. Device class: 2.

Clearance details

Applicant: Team Innovations, Inc.
Product code: Code DRX
Device class: Class 2
Regulation: 21 CFR 870.2360
Advisory panel: Cardiovascular
Date received: 2010-06-07
Decision date: 2010-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Allis, WI, US

Download summary PDF View on FDA.gov ↗

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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.