FUKUDA DENSHI MODEL AU-5001-5003 THERMAL— 510(k) K852487

Name: FDA 510(k) clearance K852487
Creator: U.S. Food and Drug Administration
Published: 1985-09-19

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K852487 for FUKUDA DENSHI MODEL AU-5001-5003 THERMAL, Substantially Equivalent on 1985-09-19. Applicant: Fukuda Denshi USA, Inc.. Device class: 1.

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1985-06-11
Decision date: 1985-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, 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.