Hexa-Temp
K-Number: K214071 · 2022-03-10
ApplicantSpident Co., Ltd.
Decision Date2022-03-10
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Hexa-Temp is a medical device manufactured by Spident Co., Ltd.. It received FDA 510(k) clearance on 2022-03-10 under approval number K214071. 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 Hexa-Temp?
Hexa-Temp is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Spident Co., Ltd.. The 510(k) number is K214071.
When was Hexa-Temp approved by the FDA?
Hexa-Temp received FDA 510(k) clearance on 2022-03-10, under approval number K214071.
What company makes Hexa-Temp?
Hexa-Temp is manufactured by Spident Co., Ltd..
What is the FDA product code for Hexa-Temp?
The FDA product code for Hexa-Temp is EBG.
Other Devices by Spident Co., 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.