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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 K202306
Device Name T3 Platform software
Applicant
Etiometry, Inc.
280 Summer St.,
4th Floor
Boston,  MA  02210
Applicant Contact Tim Hanson
Correspondent
Etiometry, Inc.
280 Summer St.,
4th Floor
Boston,  MA  02210
Correspondent Contact Tim Hanson
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
PLB  
Date Received08/14/2020
Decision Date 11/25/2020
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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