The following data is part of a premarket notification filed by Neotonus, Inc. with the FDA for Pns Magnetic Stimulator System.
| Device ID | K002889 |
| 510k Number | K002889 |
| Device Name: | PNS MAGNETIC STIMULATOR SYSTEM |
| Classification | Stimulator, Nerve, Peripheral, Electric |
| Applicant | NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Sheila Hemeon-heyer |
| Correspondent | Sheila Hemeon-heyer NEOTONUS, INC. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | KOI |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-15 |
| Decision Date | 2001-04-06 |