EchoGo Amyloidosis (1.0)— 510(k) K240860

Substantially Equivalent

Ultromics Limited

FDA 510(k) clearance K240860 for EchoGo Amyloidosis (1.0), Substantially Equivalent on 2024-11-15. Applicant: Ultromics Limited. Device class: 2.

Clearance details

Applicant: Ultromics Limited
Product code: Code SDJ
Device class: Class 2
Regulation: 21 CFR 870.2200
Advisory panel: Cardiovascular
Date received: 2024-03-28
Decision date: 2024-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code SDJ

K250151 — Us2.ca2025-06-20
K243866 — InVision Precision Cardiac Amyloid2025-05-21

More clearances from Ultromics Limited

K240013 — EchoGo Heart Failure (2.0)2024-09-23
K222463 — EchoGo Heart Failure2022-11-23
K213275 — EchoGo Core (2.0)2021-12-20

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