21 CFR 882.1565 — Brain Temperature Measurement System
Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1565
Identification
A brain temperature measurement system is an externally placed, prescription device intended to measure brain temperature. The BTNeo System is indicated for measurement of a neonate's brain temperature, intended to be displayed along with core temperature, for use by qualified healthcare professionals that care for neonates (from birth through the first 28 days of life) in intensive care units, operating rooms, and recovery rooms.
Classification Rationale
Class II (special controls). The device is granted De Novo classification under 21 CFR 882.1565, as the probable benefits outweigh the probable risks, and the risks can be mitigated by the use of general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QSL | Brain Temperature Measurement System | 2 | 1 | SaMD |
Special Controls
QSL — Brain Temperature Measurement System
In combination with the general controls of the FD&C Act, the brain temperature measurement system is subject to the following special controls:
De Novo Order DEN200042
