510(k) K193110
K193110 is an FDA 510(k) premarket notification submitted by 3M Healthcare for the device "3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E". The FDA issued a decision of Substantially Equivalent on March 13, 2020. The device falls under product code QKM (A Chemical Vapor Sterilization Multivariable Chemical Indicator), a Class II device regulated under 21 CFR 880.2800. 3M Healthcare has at least 10 other 510(k) clearances on record.
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.