De Novo DEN210037

Device

SoClean 3+ Bacterial Reduction Device

Contact

george peters

De Novo number

DEN210037

Product code

QXQ

Regulation

880.6993

Classification name

respiratory accessory microbial reduction device.

Decision

granted (DENG)

Decision date

2024-08-12

Date received

2021-09-15

Classification advisory

General Hospital

Review advisory

General Hospital

Type

Direct