De Novo DEN210015

Device

Sunrise Sleep Disorder Diagnostic Aid

Contact

francois naye

De Novo number

DEN210015

Product code

QRS

Regulation

868.2376

Classification name

device for sleep apnea testing based on mandibular movement

Decision

granted (DENG)

Decision date

2022-01-07

Date received

2021-04-02

Classification advisory

Ear Nose & Throat

Review advisory

Anesthesiology

Type

Direct