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SBEClass II

Digital Physical/Chemical Sterilization Process Sensor

21 CFR 880.2801 / General Hospital
FDA source (opens on fda.gov)

SBE is the FDA product code for Digital Physical/Chemical Sterilization Process Sensor, a class II device type, regulated under 21 CFR 880.2801. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SBE
Device name
Digital Physical/Chemical Sterilization Process Sensor
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.
Regulation
21 CFR 880.2801
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SBE

By decision year
1 clearance under product code SBE with a decision year between 2024 and 2024, 2024 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SBE by decision year
YearClearances
20241

Applicants with the most clearances

Product code SBE
Applicants holding the most 510(k) clearances under product code SBE
ApplicantClearances
3M Company1

Companies listing this code with FDA

Companies whose registered establishments list this code