EchoGo Heart Failure— 510(k) K222463
Substantially EquivalentUltromics Limited
FDA 510(k) clearance K222463 for EchoGo Heart Failure, Substantially Equivalent on 2022-11-23. Applicant: Ultromics Limited. Device class: 2.
Clearance details
- Applicant
- Ultromics Limited
- Product code
- Code QUO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oxford, GB
Recent devices under product code QUO
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