Dopplex IOP8-DK2-Usa
Dopplex IOP8-DK2-Usa is a Class II device made by Huntleigh Healthcare, Ltd., cleared under FDA 510(k) K032315 on 18 Nov 2004 and listed in FDA GUDID since 18 Aug 2016 (UDI-DI 05051968020154), active as of 23 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 | Number05051968020154 | Date18 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK032315 | Date18 Nov 2004 | StatusActive |
Official records
- AccessGUDID record 05051968020154
- FDA 510(k) database K032315
Across registries
- FDA 510(k) K032315 decided 18 Nov 2004 Active
- FDA GUDID UDI-DI 05051968020154 listed 18 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K032315
- Listed FDA GUDID 05051968020154
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Dopplex
- Generic name
- Invasive vascular ultrasound system probe
- Model / Ref / Catalog
- IOP8-DK2-USA
- Primary DI / UDI-DI
- 05051968020154
- 510(k) Number
- FDA product code
- ITX
- GMDN term
- Invasive vascular ultrasound system probe
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
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