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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, Mobile
510(k) Number K890306
Device Name BCM-ARC 105 X-RAY MOBILE UNIT
Applicant
B C Medical , Ltd.
3755 Richelieu
St-Hubert, Qc Canada
J3y 7p9,  CA
Applicant Contact CHARLES L BECHET
Correspondent
B C Medical , Ltd.
3755 Richelieu
St-Hubert, Qc Canada
J3y 7p9,  CA
Correspondent Contact CHARLES L BECHET
Regulation Number892.1720
Classification Product Code
IZL  
Date Received01/23/1989
Decision Date 04/17/1989
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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