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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Heart Failure Status Indicator
510(k) Number K240013
Device Name EchoGo Heart Failure (2.0)
Applicant
Ultromics Limited
4630 Kingsgate
Cascade Way, Oxford Business Park
Oxford,  GB OX4 2SU
Applicant Contact Elena Traistaru
Correspondent
Ultromics Limited
4630 Kingsgate
Cascade Way, Oxford Business Park
Oxford,  GB OX4 2SU
Correspondent Contact Elena Traistaru
Regulation Number870.2200
Classification Product Code
QUO  
Date Received01/02/2024
Decision Date 09/23/2024
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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