DI-2000— 510(k) K943602

Substantially Equivalent

Miles Inc., Agfa Division

FDA 510(k) clearance K943602 for DI-2000, Substantially Equivalent on 1995-05-12. Applicant: Miles Inc., Agfa Division. Device class: 1.

Clearance details

Applicant: Miles Inc., Agfa Division
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 1994-07-25
Decision date: 1995-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield Park, NJ, US

Download summary PDF View on FDA.gov ↗

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