Class Class II
Aulisa Temperature Module (TM0002) (K240220)
Description
Aulisa Temperature Module (TM0002) by Taiwan Aulisa Medical Devices Technologies, Inc., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240220
Clearance Date2024-09-27
Clearance TypeTraditional
Product CodeFLL
Regulation Number880.2910
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240220
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Aulisa Temperature Module (TM0002) (K240220) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitori... | Taiwan Aulisa Medical Devices Techn... | 2022 |
| K181013 | Fever Scout | VivaLNK, Inc. | 2018 |
Trace the full predicate network for K240220
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.