DEN230011
- 510(k) number
- DEN230011
- Device name
- OcuCool
- Applicant
- Recensmedical, Inc. KR
- Product code
- QZQ not yet in the FDA classification database
- Decision date
- 2024-09-30
- Date received
- 2023-02-16
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Unknown
Official FDA record: DEN230011
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.