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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K210133
Device Name Current Health Monitoring System Gen 2 (G2)
Applicant
Current Health
Playfair House, 6 Broughton St. Lane
Edinburgh,  GB EH 1 3LY
Applicant Contact Phil Bromley
Correspondent
Current Health
Playfair House, 6 Broughton St. Lane
Edinburgh,  GB EH 1 3LY
Correspondent Contact Phil Bromley
Regulation Number870.2300
Classification Product Code
MSX  
Subsequent Product Codes
BZG   BZQ   DQA   DRG   FLL  
Date Received01/19/2021
Decision Date 09/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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