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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 K213234
Device Name CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
Applicant
GE Medical Systems Information Technologies, Inc.
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Joel Kent
Correspondent
GE Medical Systems Information Technologies, Inc.
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Joel Kent
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CCK   DPS   DPZ   DQA  
DQK   DRT   DSI   DSJ   DSK   DXN  
FLL   MLD   MUD   QEM  
Date Received09/30/2021
Decision Date 04/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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