Hub P005324
by EchoNous
Hub P005324 is a Class II device made by EchoNous, cleared under FDA 510(k) K181574 on 10 Jul 2018 and listed in FDA GUDID since 9 Aug 2018 (UDI-DI 09353278000069), 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 | Number09353278000069 | Date9 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181574 | Date10 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 09353278000069
- FDA 510(k) database K181574
Across registries
- FDA 510(k) K181574 decided 10 Jul 2018 Active
- FDA GUDID UDI-DI 09353278000069 listed 9 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K181574
- Listed FDA GUDID 09353278000069
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Hub
- Generic name
- Ultrasound imaging system multi-transducer connection unit
- Model / reference
- P005324
- Primary DI / UDI-DI
- 09353278000069
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- Ultrasound imaging system multi-transducer connection unit
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
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