DRYSTAR AXYS, MODEL EYZ4E— 510(k) K072680

Name: FDA 510(k) clearance K072680
Creator: U.S. Food and Drug Administration
Published: 2007-10-25

Substantially Equivalent

Agfa Healthcare Corporation

FDA 510(k) clearance K072680 for DRYSTAR AXYS, MODEL EYZ4E, Substantially Equivalent on 2007-10-25. Applicant: Agfa Healthcare Corporation. Device class: 2.

Clearance details

Applicant: Agfa Healthcare Corporation
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 2007-09-24
Decision date: 2007-10-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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