LR 5200 LASER FILM RECORDER— 510(k) K964414

Substantially Equivalent

Bayer Corp., Agfa Div.

FDA 510(k) clearance K964414 for LR 5200 LASER FILM RECORDER, Substantially Equivalent on 1997-01-27. Applicant: Bayer Corp., Agfa Div.. Device class: 2.

Clearance details

Applicant
Bayer Corp., Agfa Div.
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
Ridgefield Park, NJ, US
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