510(k) K193110
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2020
- Date Received
- November 12, 2019
- Clearance Type
- Traditional
- 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.