| Device Type ID | 3741 |
| Device Name | Test, Temperature Discrimination |
| Physical State | Enforcement Discretion Applies To Devices That Do Not Provide An Interpretation Or Clinical Implication Of The Measurement, In Accordance With The FDA Guidance, “Intent To Exempt Certain Unclassified, Class II, And Class I Reserved Medical Devices Fr |
| Regulation Description | Two-point Discriminator. |
| 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 | Enforcement Discretion |
| CFR Regulation Number | 882.1200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LQW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3741 |
| Device | Test, Temperature Discrimination |
| Product Code | LQW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Two-point Discriminator. |
| CFR Regulation Number | 882.1200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PROSENEX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |