Caretalk TH1009N
by Shenzhen Dongdixin Technology Co., Ltd.
Caretalk TH1009N is a Class II device made by Shenzhen Dongdixin Technology Co., Ltd., cleared under FDA 510(k) K161735 on 17 Nov 2016 and listed in FDA GUDID since 7 Apr 2020 (UDI-DI 06926408700455), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06926408700455 | Date7 Apr 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK161735 | Date17 Nov 2016 | StatusActive |
Official records
- AccessGUDID record 06926408700455
- FDA 510(k) database K161735
Across registries
- FDA 510(k) K161735 decided 17 Nov 2016 Active
- FDA GUDID UDI-DI 06926408700455 listed 7 Apr 2020 Listed
Timeline
- Cleared FDA 510(k) K161735
- Listed FDA GUDID 06926408700455
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Caretalk
- Generic name
- Infrared patient thermometer, skin
- Model / reference
- TH1009N
- Primary DI / UDI-DI
- 06926408700455
- 510(k) Number
- FDA product code
- FLL
- GMDN term
- Infrared patient thermometer, skin
- Device class
- Class II
- Regulation number
- 880.2910
- GUDID distribution status
- In Commercial Distribution
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