EDEC-100— 510(k) K843443

Substantially Equivalent

Electromed Intl., Ltd.

FDA 510(k) clearance K843443 for EDEC-100, Substantially Equivalent on 1985-03-01. 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: 1984-09-04
Decision date: 1985-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Willoughby, OH, 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.