Linear probe L8M-T
by CHISON Medical Technologies Co., Ltd.
Linear probe L8M-T is a Class II device made by CHISON Medical Technologies Co., Ltd., cleared under FDA 510(k) K200780 on 5 Aug 2020 and listed in FDA GUDID since 2 Nov 2021 (UDI-DI 06945121413466), 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 | Number06945121413466 | Date2 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK200780 | Date5 Aug 2020 | StatusActive |
Official records
- AccessGUDID record 06945121413466
- FDA 510(k) database K200780
Across registries
- FDA 510(k) K200780 decided 5 Aug 2020 Active
- FDA GUDID UDI-DI 06945121413466 listed 2 Nov 2021 Listed
Timeline
- Cleared FDA 510(k) K200780
- Listed FDA GUDID 06945121413466
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Linear probe
- Generic name
- Extracorporeal ultrasound imaging transducer, hand-held
- Model / reference
- L8M-T
- Primary DI / UDI-DI
- 06945121413466
- 510(k) Number
- FDA product code
- ITX
- GMDN term
- Extracorporeal ultrasound imaging transducer, hand-held
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
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