DROWZLE Pro 2.0
DROWZLE Pro 2.0 is a Class II device made by Resonea, Inc., cleared under FDA 510(k) K173974 on 14 Jul 2019 and listed in FDA GUDID since 4 Nov 2020 (UDI-DI 00860004872405), 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 | GUDID listing | Number00860004872405 | Date4 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK173974 | Date14 Jul 2019 | StatusActive |
Official records
- AccessGUDID record 00860004872405
- FDA 510(k) database K173974
Across registries
- FDA 510(k) K173974 decided 14 Jul 2019 Active
- FDA GUDID UDI-DI 00860004872405 listed 4 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K173974
- Listed FDA GUDID 00860004872405
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DROWZLE Pro
- Generic name
- Home-use sleep apnoea recording system
- Model / reference
- 2.0
- Primary DI / UDI-DI
- 00860004872405
- 510(k) Number
- FDA product code
- MNR
- GMDN term
- Home-use sleep apnoea recording system
- Device class
- Class II
- Regulation number
- 868.2375
- GUDID distribution status
- In Commercial Distribution
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