Trio 300
510(k) K990787
Trio 300 is a Class II device made by Ito Co., Ltd., cleared under FDA 510(k) K990787 on 20 Oct 1999, 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 | FDA 510(k)SESE | NumberK990787 | Date20 Oct 1999 | StatusActive |
Official records
- FDA 510(k) database K990787
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IPF
- Device class
- Class II
- Regulation
- 21 CFR Part 890.5850
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K990787
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 | |||
|---|---|---|---|---|
| Trio*Stim 215 ME 215 | ME 215 / ME 215 | 00816864020401 | Weight 168 g | On the market |
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