OSE · Patient Specific Manual Navigation System
Neurology · 21 CFR 882.4560 · Class 2
Overview
| Product Code | OSE |
|---|---|
| Device Name | Patient Specific Manual Navigation System |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
| Review Panel | Neurology |
Identification
A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
