EchoGo Amyloidosis (1.0)
K-Number: K240860 · 2024-11-15
ApplicantUltromics Limited
Decision Date2024-11-15
Product CodeSDJ
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EchoGo Amyloidosis (1.0) is a medical device manufactured by Ultromics Limited. It received FDA 510(k) clearance on 2024-11-15 under approval number K240860. The device is classified under product code SDJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EchoGo Amyloidosis (1.0)?
EchoGo Amyloidosis (1.0) is a medical device that received FDA 510(k) clearance on 2024-11-15. It is manufactured by Ultromics Limited. The 510(k) number is K240860.
When was EchoGo Amyloidosis (1.0) approved by the FDA?
EchoGo Amyloidosis (1.0) received FDA 510(k) clearance on 2024-11-15, under approval number K240860.
What company makes EchoGo Amyloidosis (1.0)?
EchoGo Amyloidosis (1.0) is manufactured by Ultromics Limited.
What is the FDA product code for EchoGo Amyloidosis (1.0)?
The FDA product code for EchoGo Amyloidosis (1.0) is SDJ.
Other Devices by Ultromics Limited
Related Devices (Code: SDJ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.