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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
Philips Medical Systems
2 Canal Park
Cambridge,  MA  02141
Applicant Contact Suzanne Goodman
Philips Medical Systems
2 Canal Park
Cambridge,  MA  02141
Correspondent Contact Suzanne Goodman
Regulation Number870.2910
Classification Product Code
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