HEARTSTART 911— 510(k) K954609

Substantially Equivalent

Laerdal Medical Corp.

FDA 510(k) clearance K954609 for HEARTSTART 911, Substantially Equivalent on 1996-01-04. Applicant: Laerdal Medical Corp..

Clearance details

Applicant: Laerdal Medical Corp.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 1995-10-04
Decision date: 1996-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wappingers Falls, NY, 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.