Tetra (TM-20); Tetra (TM-50)
K-Number: K251105 · 2025-12-22
ApplicantEmed Technologies Corporation
Decision Date2025-12-22
Product CodePKP
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Tetra (TM-20); Tetra (TM-50) is a medical device manufactured by Emed Technologies Corporation. It received FDA 510(k) clearance on 2025-12-22 under approval number K251105. The device is classified under product code PKP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tetra (TM-20); Tetra (TM-50)?
Tetra (TM-20); Tetra (TM-50) is a medical device that received FDA 510(k) clearance on 2025-12-22. It is manufactured by Emed Technologies Corporation. The 510(k) number is K251105.
When was Tetra (TM-20); Tetra (TM-50) approved by the FDA?
Tetra (TM-20); Tetra (TM-50) received FDA 510(k) clearance on 2025-12-22, under approval number K251105.
What company makes Tetra (TM-20); Tetra (TM-50)?
Tetra (TM-20); Tetra (TM-50) is manufactured by Emed Technologies Corporation.
What is the FDA product code for Tetra (TM-20); Tetra (TM-50)?
The FDA product code for Tetra (TM-20); Tetra (TM-50) is PKP.
Other Devices by Emed Technologies Corporation
Related Devices (Code: PKP)
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.