FC-700 DEFIBRILLATOR— 510(k) K850618

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K850618 for FC-700 DEFIBRILLATOR, Substantially Equivalent on 1985-04-19. Applicant: Fukuda Denshi USA, Inc..

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code LDD
Advisory panel: Cardiovascular
Date received: 1985-02-15
Decision date: 1985-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, 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.