K233681
- 510(k) number
- K233681
- Device name
- ConFirm 20 Minute Incubator
- Applicant
- STERIS Corporation OH · US
- Product code
- FRC — Indicator, Biological Sterilization Process
- Decision date
- 2023-12-15
- Date received
- 2023-11-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233681.pdf
Official FDA record: K233681
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.