510(k) DEN230007

Clearance Details

Decision

DENG (De Novo Granted)

Decision Date

September 1, 2023

Date Received

February 1, 2023

Clearance Type

Direct

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Whole Room Microbial Reduction Device

Device Class

Class II

Regulation Number

880.6510

Review Panel

HO

Submission Type

A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.