AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033— 510(k) K931883

Name: FDA 510(k) clearance K931883
Creator: U.S. Food and Drug Administration
Published: 1993-08-23

Substantially Equivalent

Alphatek Corp.

FDA 510(k) clearance K931883 for AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033, Substantially Equivalent on 1993-08-23. Applicant: Alphatek Corp.. Device class: 2.

Clearance details

Applicant: Alphatek Corp.
Product code: Code IXW
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1993-04-14
Decision date: 1993-08-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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