DRYSTAR 4500 PRINTER, MODEL 4500— 510(k) K010275

Substantially Equivalent

Agfa Medical Imaging

FDA 510(k) clearance K010275 for DRYSTAR 4500 PRINTER, MODEL 4500, Substantially Equivalent on 2001-04-27. Applicant: Agfa Medical Imaging. Device class: 2.

Clearance details

Applicant
Agfa Medical Imaging
Product code
Code LMC
Device class
Class 2
Regulation
21 CFR 892.2040
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Rockville, MD, US
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