Linear probe D12L40L
by CHISON Medical Technologies Co., Ltd.
Linear probe D12L40L is a Class II device made by CHISON Medical Technologies Co., Ltd., cleared under FDA 510(k) K153085 on 21 Dec 2015 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 06945121400169), 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 | Number06945121400169 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK153085 | Date21 Dec 2015 | StatusActive |
Official records
- AccessGUDID record 06945121400169
- FDA 510(k) database K153085
Across registries
- FDA 510(k) K153085 decided 21 Dec 2015 Active
- FDA GUDID UDI-DI 06945121400169 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K153085
- Listed FDA GUDID 06945121400169
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Linear probe
- Generic name
- Foetal Doppler system probe
- Model / reference
- D12L40L
- Primary DI / UDI-DI
- 06945121400169
- 510(k) Number
- FDA product code
- ITX
- GMDN term
- Foetal Doppler system probe
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Foetal Doppler system probe.
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