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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cleaner, Air, Medical Recirculating
510(k) Number K220298
Device Name CerroZone Mobile
Applicant
CerroZone
P.O.Box 66800
St. Louis,  MO  63166
Applicant Contact Marlon E. Robinson
Correspondent
RQM+
2251 San Diego Avenue, Ste B-257
San Diego,  CA  92110
Correspondent Contact Matthieu Kirkland
Regulation Number880.5045
Classification Product Code
FRF  
Date Received02/02/2022
Decision Date 07/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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