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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Angiographic
510(k) Number K945540
Device Name CAAS II
Applicant
Pie Medical Equipment B.V.
Philipsweg 1
Maastricht,  NL 6227 AJ
Applicant Contact FRANK ANIBA
Correspondent
Pie Medical Equipment B.V.
Philipsweg 1
Maastricht,  NL 6227 AJ
Correspondent Contact FRANK ANIBA
Regulation Number892.1600
Classification Product Code
IZI  
Date Received11/14/1994
Decision Date 06/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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