CD-R STATION AND VRS-2000— 510(k) K974255

Name: FDA 510(k) clearance K974255
Creator: U.S. Food and Drug Administration
Published: 1998-01-27

Substantially Equivalent

Electromed Intl., Ltd.

FDA 510(k) clearance K974255 for CD-R STATION AND VRS-2000, Substantially Equivalent on 1998-01-27. Applicant: Electromed Intl., Ltd.. Device class: 1.

Clearance details

Applicant: Electromed Intl., Ltd.
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1997-11-13
Decision date: 1998-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St-Eustache, Quebec, CA

Download summary PDF View on FDA.gov ↗

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