EchoGo Heart Failure

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

Ultromics Limited

The following data is part of a premarket notification filed by Ultromics Limited with the FDA for Echogo Heart Failure.

Pre-market Notification Details

• Device ID: K222463
• 510k Number: K222463
• Device Name: EchoGo Heart Failure
• Classification: 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
• Applicant: Ultromics Limited 4630 Kingsgate Cascade Way, Oxford Business Park Oxford, GB OX4 2SU
• Contact: Jaco Jacobs
• Correspondent: Jaco Jacobs; Ultromics Limited 4630 Kingsgate Cascade Way, Oxford Business Park Oxford, GB OX4 2SU
• Product Code: QUO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2022-08-15
• Decision Date: 2022-11-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05060634690041	K222463	000