HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE— 510(k) K992543

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K992543 for HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE, Substantially Equivalent on 2000-05-18. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code MKJ
Advisory panel: Cardiovascular
Date received: 1999-07-30
Decision date: 2000-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, 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.