LINE POWERED LOW ENERGY DEFIBRILLATOR II— 510(k) K813471

Name: FDA 510(k) clearance K813471
Creator: U.S. Food and Drug Administration
Published: 1981-12-29

Substantially Equivalent

Narco Scientific

FDA 510(k) clearance K813471 for LINE POWERED LOW ENERGY DEFIBRILLATOR II, Substantially Equivalent on 1981-12-29. Applicant: Narco Scientific. Device class: 2.

Clearance details

Applicant: Narco Scientific
Product code: Code LDD
Device class: Class 2
Regulation: 21 CFR 870.5300
Advisory panel: Cardiovascular
Date received: 1981-12-14
Decision date: 1981-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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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.