510(k) K240013
- Device
- EchoGo Heart Failure (2.0)
- Applicant
- Ultromics Limited
- 510(k) number
- K240013
- Product code
- QUO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-23
- Date received
- 2024-01-02
- Regulation
- 870.2200
- Classification name
- Adjunctive Heart Failure Status Indicator
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Elena Traistaru
- Address
- 4630 Kingsgate Cascade Way, Oxford Business Park Oxford GB OX4 2SU OX4 2SU
FDA Registration Numbers#
- 2951215
- 3018772859
- 3016585383