LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES)— 510(k) K895379

Substantially Equivalent

Physio-Control Corp.

FDA 510(k) clearance K895379 for LOW ENERGY DC - DEFIBRILLATOR (INCLUDING PADDLES), Substantially Equivalent on 1990-02-26. Applicant: Physio-Control Corp..

Clearance details

Applicant: Physio-Control Corp.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1989-08-30
Decision date: 1990-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, 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.