Polysmith Version 10.0
Polysmith Version 10.0 is a Class II device made by Neurotronics, LLC, listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00817111020748), registry data as of 21 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00817111020748 | Date22 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00817111020748
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Sleep disorder interpretive software, professional-only
- Model / reference
- 10.0
- Primary DI / UDI-DI
- 00817111020748
- FDA product code
- GWL, MNR, DQA, OLV, OLZ
- GMDN term
- Sleep disorder interpretive software, professional-only
- Device class
- Class II
- Regulation number
- 882.1835, 868.2375, 870.2700, 882.1400
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code GWL (Amplifier, Physiological Signal).
- X-trodes System M by X-Trodes
- Grass Model 15 Neurodata Amplifier System by Astro-Med, Inc.
- Response System TN-3000 by Tracor Instruments, Inc.
- Nicolet Amp 6R11 System by Nicolet Biomedical Instruments
- NICOLET WIRELESS EEG by Carefusion 209, Inc.
- REFA, PHYSIOLOGICAL AMPLIFIER by Tms International BV
- SENSOR AMPLIFIER by Pro-Tech Services, Inc.
- NEUROPACK II 5100 by NIHON KOHDEN AMERICA, INC.
- BE Plus LTM Amplifier GWI Amplifier by EB Neuro S.p.A.
- PORTI 7 PHYSIOLOGICAL AMPLIFIER by Tms International BV