360D DC DEFIBRILLATOR— 510(k) K874091

Substantially Equivalent

Medac, Inc.

FDA 510(k) clearance K874091 for 360D DC DEFIBRILLATOR, Substantially Equivalent on 1987-11-23. Applicant: Medac, Inc..

Clearance details

Applicant: Medac, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1987-10-07
Decision date: 1987-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tualatin, 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.