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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 K222463
Device Name EchoGo Heart Failure
Applicant
Ultromics Limited
4630 Kingsgate
Cascade Way, Oxford Business Park
Oxford,  GB OX4 2SU
Applicant Contact Jaco Jacobs
Correspondent
Ultromics Limited
4630 Kingsgate
Cascade Way, Oxford Business Park
Oxford,  GB OX4 2SU
Correspondent Contact Jaco Jacobs
Regulation Number870.2200
Classification Product Code
QUO  
Date Received08/15/2022
Decision Date 11/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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