CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS— 510(k) K981280

Name: FDA 510(k) clearance K981280
Creator: U.S. Food and Drug Administration
Published: 1998-04-30

Substantially Equivalent

Bayer Corp., Agfa Div.

FDA 510(k) clearance K981280 for CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS, Substantially Equivalent on 1998-04-30. Applicant: Bayer Corp., Agfa Div.. Device class: 2.

Clearance details

Applicant: Bayer Corp., Agfa Div.
Product code: Code IXW
Device class: Class 2
Regulation: 21 CFR 892.1900
Advisory panel: Radiology
Date received: 1998-04-08
Decision date: 1998-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ridgefield Park, NJ, US

Download summary PDF View on FDA.gov ↗

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