ADC COMPACT PLUS— 510(k) K013138

Substantially Equivalent

Agfa-Gevaert AG

FDA 510(k) clearance K013138 for ADC COMPACT PLUS, Substantially Equivalent on 2001-09-28. Applicant: Agfa-Gevaert AG. Device class: 2.

Clearance details

Applicant
Agfa-Gevaert AG
Product code
Code MQB
Device class
Class 2
Regulation
21 CFR 892.1680
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Rockville, MD, US
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