CURA-Temp
K-Number: K202965 · 2022-12-21
ApplicantMgnewton , Ltd.
Decision Date2022-12-21
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
CURA-Temp is a medical device manufactured by Mgnewton , Ltd.. It received FDA 510(k) clearance on 2022-12-21 under approval number K202965. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CURA-Temp?
CURA-Temp is a medical device that received FDA 510(k) clearance on 2022-12-21. It is manufactured by Mgnewton , Ltd.. The 510(k) number is K202965.
When was CURA-Temp approved by the FDA?
CURA-Temp received FDA 510(k) clearance on 2022-12-21, under approval number K202965.
What company makes CURA-Temp?
CURA-Temp is manufactured by Mgnewton , Ltd..
What is the FDA product code for CURA-Temp?
The FDA product code for CURA-Temp is EBG.
Other Devices by Mgnewton , Ltd.
Related Devices (Code: EBG)
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.