Us2.ca— 510(k) K250151

Substantially Equivalent

Eko.Ai Pte Ltd. D/B/A Us2.Ai

FDA 510(k) clearance K250151 for Us2.ca, Substantially Equivalent on 2025-06-20. Applicant: Eko.Ai Pte Ltd. D/B/A Us2.Ai. Device class: 2.

Clearance details

Applicant: Eko.Ai Pte Ltd. D/B/A Us2.Ai
Product code: Code SDJ
Device class: Class 2
Regulation: 21 CFR 870.2200
Advisory panel: Cardiovascular
Date received: 2025-01-21
Decision date: 2025-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Recent devices under product code SDJ

K243866 — InVision Precision Cardiac Amyloid2025-05-21
K240860 — EchoGo Amyloidosis (1.0)2024-11-15

More clearances from Eko.Ai Pte Ltd. D/B/A Us2.Ai

K233676 — Us2.v22024-04-01
K210791 — Us2.v12021-07-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.