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510(k) K222463

Device
EchoGo Heart Failure
Applicant
Ultromics Limited
510(k) number
K222463
Product code
QUO
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-23
Date received
2022-08-15
Regulation
510(k) Premarket Notification
Classification name
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jaco Jacobs
Address
4630 Kingsgate Cascade Way, Oxford Business Park Oxford GB OX4 2SU OX4 2SU

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QUO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251293CardioVisionIcardio.Ai2025-11-21
K240013EchoGo Heart Failure (2.0)Ultromics Limited2024-09-23
K223905Vivio® LVEDP SystemAvicena, LLC2023-10-06

Legacy Summary#

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FDA Review#

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