COMPACT-X— 510(k) K950694

Substantially Equivalent

Electromed Intl., Ltd.

FDA 510(k) clearance K950694 for COMPACT-X, Substantially Equivalent on 1995-03-31. 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: 1995-02-14
Decision date: 1995-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St-Eustache, Quebec, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code IZO

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K952822 — SHIMADZU X-RAY HIGH VILTAGE GENERATOR AHD150G1995-07-12
K952265 — MILESTONW 350/450/550HF, PCX N350/450/550HF, TOP-X 350/450/550HF RADIOGRAPHIC X-RAY GENERATOR1995-07-06

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K971176 — VIEW ARCHIVING STATION1997-09-03

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