De Novo DEN170044

Device: ClearMate
Contact: kipton lade
De Novo number: DEN170044
Product code: QFB
Regulation: 868.5480
Classification name: isocapnic ventilation device
Decision: granted (DENG)
Decision date: 2019-03-14
Date received: 2017-08-18
Classification advisory: General Hospital
Review advisory: Anesthesiology
Type: Direct

Current FDA Classification#

Product code: QFB
Device name: Isocapnic Ventilation Device
Medical specialty: General Hospital
Device class: 2
Regulation: 868.5480
Implant: N
Life sustain/support: N