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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 K946378
Device Name BCM 400CP
Applicant
B C Medical , Ltd.
3755 Richelieu
St-Hubert, Qc Canada
J3y 7p9,  CA
Applicant Contact CHARLES BECHET
Correspondent
B C Medical , Ltd.
3755 Richelieu
St-Hubert, Qc Canada
J3y 7p9,  CA
Correspondent Contact CHARLES BECHET
Regulation Number892.1600
Classification Product Code
IZI  
Date Received12/23/1994
Decision Date 05/04/1995
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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