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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K211900
Device Name Patient Information Center iX
Applicant
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Str.2
Böblingen,  DE 71034
Applicant Contact Peng Cui
Correspondent
Philips Medizin Systeme Böblingen GmbH
Hewlett-Packard Str.2
Böblingen,  DE 71034
Correspondent Contact Peng Cui
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DSH   DSI   MLD   MSX   OUG  
Date Received06/21/2021
Decision Date 03/04/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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