FDA 510K (K190297) Indicator, Biological Sterilization Process
FDA 510K (K190297) Indicator, Biological Sterilization Process
Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K190297
Device Name Celerity HP Incubator
Applicant Steris Corporation
Regulation Number 880.2800
Classification Product Code FRC
Date Received 02/11/2019
Decision Date 05/14/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
Total pages: 678
Fully redacted pages: 619
Content pages: 59
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