BXM · Stimulator, Nerve, Ac-Powered
Anesthesiology · 21 CFR 868.2775 · Class 2
Overview
| Product Code | BXM |
|---|---|
| Device Name | Stimulator, Nerve, Ac-Powered |
| Regulation | 21 CFR 868.2775 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.
Classification Rationale
Class II (performance standards).
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013215 | MODIFIED INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | Oct 16, 2001 | SESE |
| K002677 | NUVASIVE INS-1 INTRAOPERATIVE NERVE SURVEILLANCE SYSTEM | Nuvasive, Inc. | Nov 13, 2000 | SESE |
| K921498 | VER MED A10011 PNS DUAL ELEMENT ELECTRODE | Vermont Medical, Inc. | Jun 9, 1993 | SESE |
| K870662 | MODEL SKCK STERILE KNOB COVER KIT | Life-Tech Intl., Inc. | Oct 28, 1987 | SESE |
Top Applicants
- Nuvasive, Inc. — 2 clearances
- Vermont Medical, Inc. — 1 clearance
- Life-Tech Intl., Inc. — 1 clearance
