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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 K200494
Device Name CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
Applicant
GE Healthcare
8200 West Tower Avenue
Milwaukee,  WI  53223
Applicant Contact Joel Kent
Correspondent
GE Healthcare
8200 West Tower Avenue
Milwaukee,  WI  53223
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  
Date Received02/28/2020
Decision Date 03/29/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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