Class Class II
Wearable Digital Thermometer (T31) (K240333)
Description
Wearable Digital Thermometer (T31) by Guangdong Genial Technology Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240333
Clearance Date2024-10-30
Clearance TypeTraditional
Product CodeFLL
Regulation Number880.2910
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240333
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. Wearable Digital Thermometer (T31) (K240333) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222588 | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 | Iweecare Co., Ltd. | 2023 |
Trace the full predicate network for K240333
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.