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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 K230571
Device Name RFP-100A Connector Cable (Single Use)
Applicant
Baylis Medical Technologies, Inc.
2645 Matheson Blvd. E.
Mississauga,  CA L4W5S4
Applicant Contact Gallone Stephanie
Correspondent
Baylis Medical Technologies, Inc.
2645 Matheson Blvd. E.
Mississauga,  CA L4W5S4
Correspondent Contact Stephanie Gallone
Regulation Number870.2900
Classification Product Code
DSA  
Date Received03/01/2023
Decision Date 05/30/2023
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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