510(k) K203284

3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator by 3M Company — Product Code QKM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2020
Date Received
November 9, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
A Chemical Vapor Sterilization Multivariable Chemical Indicator
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type

A chemical vapor sterilization multivariable chemical indicator monitors two or more parameters of a chemical vapor sterilization process.