Cleared Traditional

COMPACT-X

K950694 · Electromed Intl., Ltd. · Radiology
Mar 1995
Decision
45d
Days
Class 1
Risk

About This 510(k) Submission

K950694 is an FDA 510(k) clearance for the COMPACT-X, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by Electromed Intl., Ltd. (St-Eustache, Quebec, CA). The FDA issued a Cleared decision on March 31, 1995, 45 days after receiving the submission on February 14, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K950694 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 1995
Decision Date March 31, 1995
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZO — Generator, High-voltage, X-ray, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1700

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