Stimulator, Nerve, Ac-Powered
FDA product code BXM · Class II (moderate risk) · 21 CFR 868.2775 · Anesthesiology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013215 | Modified INS-1 Intraoperative Nerve Surveillance SystemBXM · Special | Nuvasive, Inc. | 10/16/2001SE |
| K002677 | Nuvasive INS-1 Intraoperative Nerve Surveillance SystemBXM · Traditional | Nuvasive, Inc. | 11/13/2000SE |
| K921498 | Ver Med A10011 PNS Dual Element ElectrodeBXM · Traditional | Vermont Medical, Inc. | 06/09/1993SE |
| K870662 | Model SKCK Sterile Knob Cover KitBXM · Traditional | Life-Tech Intl., Inc. | 10/28/1987SE |