The following data is part of a premarket notification filed by Cerrozone with the FDA for Cerrozone Mobile.
Device ID | K220298 |
510k Number | K220298 |
Device Name: | CerroZone Mobile |
Classification | Cleaner, Air, Medical Recirculating |
Applicant | CerroZone P.O.Box 66800 St. Louis, MO 63166 |
Contact | Marlon E. Robinson |
Correspondent | Matthieu Kirkland RQM+ 2251 San Diego Avenue, Ste B-257 San Diego, CA 92110 |
Product Code | FRF |
CFR Regulation Number | 880.5045 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-02 |
Decision Date | 2022-07-01 |