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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)
510(k) Number K023334
Device Name BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
Applicant
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 33
Mississauga, Ontario,  CA L4W-4T7
Applicant Contact AMANDA HARTLEY
Correspondent
Baylis Medical Co., Inc.
5160 Explorer Dr., Unit 33
Mississauga, Ontario,  CA L4W-4T7
Correspondent Contact AMANDA HARTLEY
Regulation Number870.2900
Classification Product Code
DSA  
Date Received10/07/2002
Decision Date 12/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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