Cleared Traditional

EDEC 60R

K880050 · Electromed Intl., Ltd. · Radiology
Feb 1988
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K880050 is an FDA 510(k) clearance for the EDEC 60R, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by Electromed Intl., Ltd. (Canada, CA). The FDA issued a Cleared decision on February 29, 1988, 54 days after receiving the submission on January 6, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K880050 FDA.gov
FDA Decision Cleared SESE
Date Received January 06, 1988
Decision Date February 29, 1988
Days to Decision 54 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

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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