FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
Us2.ca
K Number: K250151
·
Decision Jun 20, 2025
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
2
Applicant Total
3
Review Days
150
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Basic Information
- Device Name
- Us2.ca
- K Number
- K250151
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Eko.Ai Pte Ltd. D/B/A Us2.Ai
- Date Received
- January 21, 2025
- Decision Date
- June 20, 2025
- Product Code
- SDJ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SDJ | Adjunctive Cardiac Amyloidosis Status Indicator | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (SDJ), ordered by most recent decision date.
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