PediGuard Threaded
Device Facts
| Record ID | K220160 |
|---|---|
| Device Name | PediGuard Threaded |
| Applicant | Spineguard S.A. |
| Product Code | PDQ · Ear, Nose, Throat |
| Decision Date | Mar 31, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.1820 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.