AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561— 510(k) K082861

Substantially Equivalent

Amco International Manufacturing & Design, Inc.

FDA 510(k) clearance K082861 for AMCO REPLACEMENT BATTERY FOR POWERHEART AED, NON-RECHARGEABLE, MODEL 2L561; G3, NON-RECHARGABLE, MODEL 7L561, Substantially Equivalent on 2008-11-25. Applicant: Amco International Manufacturing & Design, Inc..

Clearance details

Applicant: Amco International Manufacturing & Design, Inc.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 2008-09-29
Decision date: 2008-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elizabeth, CO, 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.