The following data is part of a premarket notification filed by Vermont Medical, Inc. with the FDA for Neuroplus, Model A10040, A10041, A10042, A10043.
| Device ID | K010638 |
| 510k Number | K010638 |
| Device Name: | NEUROPLUS, MODEL A10040, A10041, A10042, A10043 |
| Classification | Electrode, Cutaneous |
| Applicant | VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Contact | Marc Fillion |
| Correspondent | Marc Fillion VERMONT MEDICAL, INC. INDUSTRIAL PARK Bellows Falls, VT 05101 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-05 |
| Decision Date | 2001-05-03 |