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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Cardiovascular Status Indicator
510(k) Number K213230
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 Number870.2200
Classification Product Code
PPW  
Subsequent Product Codes
MWI   PLB  
Date Received09/29/2021
Decision Date 06/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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