| Device Type ID | 3728 |
| Device Name | Device, Temperature Measurement, Direct Contact, Powered |
| Regulation Description | Powered Direct-contact Temperature 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) |
| CFR Regulation Number | 882.1570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HCS |
| 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 | 3728 |
| Device | Device, Temperature Measurement, Direct Contact, Powered |
| Product Code | HCS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Direct-contact Temperature Measurement Device. |
| CFR Regulation Number | 882.1570 [🔎] |
| Device Problems | |
|---|---|
Contamination During Use | 1 |
| Total Device Problems | 1 |