LIFEPAK 12 DEFIBRILLATOR/MONITOR— 510(k) K041459

Substantially Equivalent

Medtronic Emergency Response Systems, Inc.

FDA 510(k) clearance K041459 for LIFEPAK 12 DEFIBRILLATOR/MONITOR, Substantially Equivalent on 2004-07-01. Applicant: Medtronic Emergency Response Systems, Inc..

Clearance details

Applicant: Medtronic Emergency Response Systems, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2004-06-02
Decision date: 2004-07-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Redmond, WA, 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.