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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 K254066
Device Name Etiometry Platform
Applicant
Etiometry, Inc.
770 Legacy Pl.
Floor 2, Suite 34
Dedham,  MA  20206
Applicant Contact Timothy Hanson
Correspondent
Etiometry, Inc.
770 Legacy Pl.
Floor 2, Suite 34
Dedham,  MA  20206
Correspondent Contact Timothy Hanson
Regulation Number870.2200
Classification Product Code
PPW  
Date Received12/18/2025
Decision Date 04/03/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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