510(k) K223715

Celerity Incubator by STERIS Corporation — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2023
Date Received
December 2, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type