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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K192875
Device Name Philips Biosensor BX100
Applicant
Philips Medical Systems
2 Canal Park
Cambridge,  MA  02141
Applicant Contact Suzanne Goodman
Correspondent
Philips Medical Systems
2 Canal Park
Cambridge,  MA  02141
Correspondent Contact Suzanne Goodman
Regulation Number870.2910
Classification Product Code
DRG  
Date Received10/08/2019
Decision Date 04/16/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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