SBE

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Digital Physical/Chemical Sterilization Process Sensor

Device class

Class II (moderate risk)

Regulation

21 CFR 880.2801

Medical specialty

General Hospital

FDA definition

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.

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