STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM— 510(k) K940539

Name: FDA 510(k) clearance K940539
Creator: U.S. Food and Drug Administration
Published: 1994-03-16

Substantially Equivalent

Standard Imaging, Inc.

FDA 510(k) clearance K940539 for STAND IMAGING DOSE CALIBRATOR SHIELDED WORK PLATFORM, Substantially Equivalent on 1994-03-16. Applicant: Standard Imaging, Inc.. Device class: 1.

Clearance details

Applicant: Standard Imaging, Inc.
Product code: Code KPY
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1994-02-07
Decision date: 1994-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Middleton, WI, US

Download summary PDF View on FDA.gov ↗

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