K233065
- 510(k) number
- K233065
- Device name
- V-PRO maX 2 Low Temperature Sterilization System
- Applicant
- Steris MA · US
- Product code
- MLR — Sterilizer, Chemical
- Decision date
- 2023-10-20
- Date received
- 2023-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K233065.pdf
Official FDA record: K233065
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.