DEN200042 is an FDA 510(k) submission for the BrainTemp Neonate System (BTNeo System). This device is classified as a Brain Temperature Measurement System (Class II - Special Controls, product code QSL).
Submitted by Brain Temp, Inc. (Bryn Mawr, US). The FDA issued a Not Cleared (DENG) decision on March 29, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1565. A Brain Temperature Measurement System Is An Externally Placed, Prescription Device Intended To Measure Brain Temperature..
| 510(k) Number | DEN200042 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | June 23, 2020 |
| Decision Date | March 29, 2022 |
| Days to Decision | 644 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | QSL - Brain Temperature Measurement System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1565 |
| Definition | A Brain Temperature Measurement System Is An Externally Placed, Prescription Device Intended To Measure Brain Temperature. |