Model Es-130
510(k) K081943
Model Es-130 is a device classified as Unclassified made by Ito Co., Ltd., cleared under FDA 510(k) K081943 on 24 Nov 2008 and registered in EUDAMED, active as of 11 Oct 2026.
Active
CE MDD 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK081943 | Date24 Nov 2008 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K081943 decided 24 Nov 2008 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- BWK
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K081943
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| ES-130 | ES-130 / ES-130 | 04983087008403 | — | On the market |
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