WR3500 AND WR3600 SERIES RECORDERS— 510(k) K894922

Name: FDA 510(k) clearance K894922
Creator: U.S. Food and Drug Administration
Published: 1990-01-26

Substantially Equivalent

Western Graphtec

FDA 510(k) clearance K894922 for WR3500 AND WR3600 SERIES RECORDERS, Substantially Equivalent on 1990-01-26. Applicant: Western Graphtec. Device class: 1.

Clearance details

Applicant: Western Graphtec
Product code: Code DSF
Device class: Class 1
Regulation: 21 CFR 870.2810
Advisory panel: Cardiovascular
Date received: 1989-08-02
Decision date: 1990-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, 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.