AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036— 510(k) K023613

Name: FDA 510(k) clearance K023613
Creator: U.S. Food and Drug Administration
Published: 2003-01-23

Substantially Equivalent

Alphatek Corp.

FDA 510(k) clearance K023613 for AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036, Substantially Equivalent on 2003-01-23. 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: 2002-10-28
Decision date: 2003-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broadview, IL, US

Download summary PDF View on FDA.gov ↗

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