510(k) K231488
Celerity HP Chemical Indicator; Celerity HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape by
Steris
— Product Code JOJ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2023
- Date Received
- May 23, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type