Aulisa Temperature Module (TM0002)
K-Number: K240220 · 2024-09-27
Decision Date2024-09-27
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Aulisa Temperature Module (TM0002) is a medical device manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. It received FDA 510(k) clearance on 2024-09-27 under approval number K240220. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aulisa Temperature Module (TM0002)?
Aulisa Temperature Module (TM0002) is a medical device that received FDA 510(k) clearance on 2024-09-27. It is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc.. The 510(k) number is K240220.
When was Aulisa Temperature Module (TM0002) approved by the FDA?
Aulisa Temperature Module (TM0002) received FDA 510(k) clearance on 2024-09-27, under approval number K240220.
What company makes Aulisa Temperature Module (TM0002)?
Aulisa Temperature Module (TM0002) is manufactured by Taiwan Aulisa Medical Devices Technologies, Inc..
What is the FDA product code for Aulisa Temperature Module (TM0002)?
The FDA product code for Aulisa Temperature Module (TM0002) is FLL.
Related Clinical Trials
Other Devices by Taiwan Aulisa Medical Devices Technologies, Inc.
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K182822Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
K183067Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System
K202497Aulisa Multiple Patient Digital Vital Sign Monitoring System
K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System
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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.