DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300— 510(k) K032635

Name: FDA 510(k) clearance K032635
Creator: U.S. Food and Drug Administration
Published: 2003-09-24

Substantially Equivalent

Agfa Corp.

FDA 510(k) clearance K032635 for DRYSTAR 5300 MEDICAL IMAGE PRINTER, MODEL 5300, Substantially Equivalent on 2003-09-24. Applicant: Agfa Corp.. Device class: 2.

Clearance details

Applicant: Agfa Corp.
Product code: Code LMC
Device class: Class 2
Regulation: 21 CFR 892.2040
Advisory panel: Radiology
Date received: 2003-08-26
Decision date: 2003-09-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Greenville, SC, US

Download summary PDF View on FDA.gov ↗

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