K250164
- 510(k) number
- K250164
- Device name
- Cassette Autoclave (ACA5)
- Applicant
- Guangzhou Ajax Medical Equipment Co., Ltd. CN
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2025-08-14
- Date received
- 2025-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250164.pdf
Official FDA record: K250164
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.