K231893
- 510(k) number
- K231893
- Device name
- LOWTEM Crystal 120
- Applicant
- Lowtem Co., Ltd. KR
- Product code
- MLR — Sterilizer, Chemical
- Decision date
- 2024-09-18
- Date received
- 2023-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K231893.pdf
Official FDA record: K231893
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.