ETD4000
K-Number: K202725 · 2021-03-26
ApplicantTherasigma, LLC
Decision Date2021-03-26
Product CodeLIH
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ETD4000 is a medical device manufactured by Therasigma, LLC. It received FDA 510(k) clearance on 2021-03-26 under approval number K202725. The device is classified under product code LIH. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ETD4000?
ETD4000 is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Therasigma, LLC. The 510(k) number is K202725.
When was ETD4000 approved by the FDA?
ETD4000 received FDA 510(k) clearance on 2021-03-26, under approval number K202725.
What company makes ETD4000?
ETD4000 is manufactured by Therasigma, LLC.
What is the FDA product code for ETD4000?
The FDA product code for ETD4000 is LIH.
Other Devices by Therasigma, LLC
Related Devices (Code: LIH)
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.