The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Nomad Sleep System Recorder, Model Pmu800.
| Device ID | K092699 |
| 510k Number | K092699 |
| Device Name: | NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 |
| Classification | Amplifier, Physiological Signal |
| Applicant | NEUROTRONICS, INC. 912 NE 2ND ST. Gainesville, FL 32601 |
| Contact | James Schubert |
| Correspondent | James Schubert NEUROTRONICS, INC. 912 NE 2ND ST. Gainesville, FL 32601 |
| Product Code | GWL |
| Subsequent Product Code | DQA |
| Subsequent Product Code | MNR |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-02 |
| Decision Date | 2010-03-18 |
| Summary: | summary |