| Device Type ID | 3654 |
| Device Name | Esthesiometer |
| Regulation Description | Esthesiometer. |
| 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 | 882.1500 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GXB |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3654 |
| Device | Esthesiometer |
| Product Code | GXB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Esthesiometer. |
| CFR Regulation Number | 882.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MEDICAL MONOFILAMENT MANUFACTURING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |