K243994
- 510(k) number
- K243994
- Device name
- Steam Sterilizer (2545D)
- Applicant
- Ningbo Ican Machines Co., Ltd. CN
- Product code
- FLE — Sterilizer, Steam
- Decision date
- 2025-06-06
- Date received
- 2024-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K243994.pdf
Official FDA record: K243994
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.