Digital Physical/Chemical Sterilization Process Sensor
SBE · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.2801
Classification
FDA Product Code
SBE
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.2801
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.