The following data is part of a premarket notification filed by National Medical Sales, Inc. with the FDA for Model 100 Nerve Stimulator.
| Device ID | K861935 |
| 510k Number | K861935 |
| Device Name: | MODEL 100 NERVE STIMULATOR |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | NATIONAL MEDICAL SALES, INC. 23881 VIA FABRICANTE UNIT 512 Mission Viejo, CA 92691 |
| Contact | William D Burch |
| Correspondent | William D Burch NATIONAL MEDICAL SALES, INC. 23881 VIA FABRICANTE UNIT 512 Mission Viejo, CA 92691 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-20 |
| Decision Date | 1986-06-13 |