Cleared Traditional

MODEL VPW2877F8, MAMMO 5 POWER SUPPLY

K942778 · Varian Assoc., Inc. · Radiology
Jul 1994
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K942778 is an FDA 510(k) clearance for the MODEL VPW2877F8, MAMMO 5 POWER SUPPLY, a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO), submitted by Varian Assoc., Inc. (Georgetown, CA). The FDA issued a Cleared decision on July 29, 1994, 46 days after receiving the submission on June 13, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number K942778 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 1994
Decision Date July 29, 1994
Days to Decision 46 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

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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