EchoNous System P006210
by EchoNous
EchoNous System P006210 is a Class II device made by EchoNous, cleared under FDA 510(k) K181574 on 10 Jul 2018 and listed in FDA GUDID since 6 May 2020 (UDI-DI 09353278000236), 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 | Number09353278000236 | Date6 May 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181574 | Date10 Jul 2018 | StatusActive |
Official records
- AccessGUDID record 09353278000236
- FDA 510(k) database K181574
Across registries
- FDA 510(k) K181574 decided 10 Jul 2018 Active
- FDA GUDID UDI-DI 09353278000236 listed 6 May 2020 Listed
Timeline
- Cleared FDA 510(k) K181574
- Listed FDA GUDID 09353278000236
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EchoNous System
- Generic name
- Hand-held ultrasound imaging system, body-surface
- Model / reference
- P006210
- Primary DI / UDI-DI
- 09353278000236
- 510(k) Number
- FDA product code
- IYO
- GMDN term
- Hand-held ultrasound imaging system, body-surface
- Device class
- Class II
- Regulation number
- 892.1560
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Hand-held ultrasound imaging system, body-surface.