EchoGo Heart Failure (2.0)— 510(k) K240013
Substantially EquivalentUltromics Limited
FDA 510(k) clearance K240013 for EchoGo Heart Failure (2.0), Substantially Equivalent on 2024-09-23. 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
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