Drowzle
510(k) K173974
Drowzle is a Class II device made by Resonea, Inc., cleared under FDA 510(k) K173974 on 14 Jul 2019, 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 | NumberK173974 | Date14 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K173974
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MNR
- Device class
- Class II
- Regulation
- 21 CFR Part 868.2375
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K173974
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 | |||
|---|---|---|---|---|
| Celeste+ 8 | 8 | 00864458000452 | — | On the market |
| DROWZLE Pro 2.0 | 2.0 | 00860004872405 | — | On the market |
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