510(k) K240860
- Device
- EchoGo Amyloidosis (1.0)
- Applicant
- Ultromics Limited
- 510(k) number
- K240860
- Product code
- SDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-15
- Date received
- 2024-03-28
- Regulation
- 870.2200
- Classification name
- Adjunctive Cardiac Amyloidosis 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
- Jaco Jacobs
- Address
- 4630 Kingsgate Cascade Way, Oxford Business Park Oxford GB OX4 2SU OX4 2SU
FDA Registration Numbers#
- 3017425832
- 3042902406
- 3016585383