GZP · Stimulator, Mechanical, Evoked Response
Neurology · 21 CFR 882.1880 · Class 2
Overview
| Product Code | GZP |
|---|---|
| Device Name | Stimulator, Mechanical, Evoked Response |
| Regulation | 21 CFR 882.1880 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 3rd-Party Reviewable | Yes |
Identification
An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191700 | EyeStat | Blinktbi, Inc. | Dec 9, 2019 | SESE |
| K913604 | SOMATOSENSORY STIMULUS SYSTEM | Biomagnetic Technologies, Inc. | Dec 9, 1991 | SESE |
Top Applicants
- Biomagnetic Technologies, Inc. — 1 clearance
- Blinktbi, Inc. — 1 clearance
