FUKUDA DENSHI EH-11— 510(k) K834059

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K834059 for FUKUDA DENSHI EH-11, Substantially Equivalent on 1985-06-21. Applicant: Fukuda Denshi USA, Inc.. Device class: 2.

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1983-11-25
Decision date: 1985-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.