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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 (Without Arrhythmia Detection Or Alarms)
510(k) Number K230626
Device Name Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™
Applicant
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Joel Kent
Correspondent
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact Joel Kent
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   DQA   DRG   MSX  
Date Received03/07/2023
Decision Date 08/11/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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