| Device Type ID | 3690 |
| Device Name | Device, Galvanic Skin Response Measurement |
| Regulation Description | Galvanic Skin Response Measurement Device. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 882.1540 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GZO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 3690 |
| Device | Device, Galvanic Skin Response Measurement |
| Product Code | GZO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Galvanic Skin Response Measurement Device. |
| CFR Regulation Number | 882.1540 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
IMPETO MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LD TECHNOLOGY LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDEIA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Inappropriate Shock | 5 |
Installation-Related Problem | 2 |
Protective Measures Problem | 2 |
| Total Device Problems | 9 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hudson Scientific LLC | II | Aug-08-2018 |
| 2 | ZYTO Technologies, Inc. | II | Jul-01-2016 |