K242795
- 510(k) number
- K242795
- Device name
- Getinge Assured MI Steam Migrating Integrator
- Applicant
- Steritec Products Mfg. (A Getinge Group Company) CO · US
- Product code
- JOJ — Indicator, Physical/Chemical Sterilization Process
- Decision date
- 2024-10-15
- Date received
- 2024-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242795.pdf
Official FDA record: K242795
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.