510(k) K250151
- Device
- Us2.ca
- Applicant
- Eko.Ai Pte Ltd. D/B/A Us2.Ai
- 510(k) number
- K250151
- Product code
- SDJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-20
- Date received
- 2025-01-21
- 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
- Hui Qun Tay
- Address
- 2 College Rd., 02-00 Singapore SG 169850 169850
FDA Registration Numbers#
- 3017425832
- 3042902406
- 3016585383