inforMED
SBEClass II

Digital Physical/chemical Sterilization Process Sensor

General Hospital · 21 CFR 880.2801

A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.

MDR events0All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances1All time

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