The following data is part of a premarket notification filed by Neurotronics, Inc. with the FDA for Nomadair Pmu810.
| Device ID | K220631 |
| 510k Number | K220631 |
| Device Name: | NomadAir PMU810 |
| Classification | Amplifier, Physiological Signal |
| Applicant | Neurotronics, Inc. 4500 NW 27th Ave STE C2 Gainesville, FL 32606 |
| Contact | James "Cody" Smith |
| Correspondent | James "Cody" Smith Neurotronics, Inc. 4500 NW 27th Ave STE C2 Gainesville, FL 32606 |
| Product Code | GWL |
| CFR Regulation Number | 882.1835 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-04 |
| Decision Date | 2022-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817111021219 | K220631 | 000 |
| 00817111021202 | K220631 | 000 |
| 00817111021196 | K220631 | 000 |
| 00817111021189 | K220631 | 000 |