EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR— 510(k) K871145

Name: FDA 510(k) clearance K871145
Creator: U.S. Food and Drug Administration
Published: 1987-03-31

Substantially Equivalent

Electromed Intl., Ltd.

FDA 510(k) clearance K871145 for EDEC 50C CONSTANT POTENTIAL X-RAY GENERATOR, Substantially Equivalent on 1987-03-31. Applicant: Electromed Intl., Ltd.. Device class: 1.

Clearance details

Applicant: Electromed Intl., Ltd.
Product code: Code IZO
Device class: Class 1
Regulation: 21 CFR 892.1700
Advisory panel: Radiology
Date received: 1987-03-23
Decision date: 1987-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

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