700-SP SERIES DISPOSABLE STIMULATION ELECTRODES— 510(k) K971148

Substantially Equivalent

Cardiotronics Systems, Inc.

FDA 510(k) clearance K971148 for 700-SP SERIES DISPOSABLE STIMULATION ELECTRODES, Substantially Equivalent on 1997-05-15. Applicant: Cardiotronics Systems, Inc..

Clearance details

Applicant: Cardiotronics Systems, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 1997-03-28
Decision date: 1997-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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Adverse events under product code MKJ

product code MKJ

Death: 961
Injury: 1,070
Malfunction: 90,719
Other: 8
Total: 92,758

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.