MODEL 43130A DEFIBRILLATOR— 510(k) K853439

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K853439 for MODEL 43130A DEFIBRILLATOR, Substantially Equivalent on 1985-10-11. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1985-08-16
Decision date: 1985-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcminnville, OR, US

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Adverse events under product code LDD

product code LDD

Death: 38
Malfunction: 522
Total: 560

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.