Polysmith Version 11.0
Polysmith Version 11.0 is a Class II device made by Neurotronics, LLC, listed in FDA GUDID since 10 Mar 2017 (UDI-DI 00817111020779), registry data as of 1 Jun 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817111020779 | Date10 Mar 2017 | StatusListed |
Official records
- AccessGUDID record 00817111020779
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Sleep disorder interpretive software, professional-only
- Model / reference
- 11.0
- Primary DI / UDI-DI
- 00817111020779
- FDA product code
- OLZ, OLV, DQA, MNR, GWL, MLO
- GMDN term
- Sleep disorder interpretive software, professional-only
- Device class
- Class II
- Regulation number
- 882.1400, 870.2700, 868.2375, 882.1835, 870.2800
- GUDID distribution status
- In Commercial Distribution
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