K240759
- 510(k) number
- K240759
- Device name
- REMEX-GR100
- Applicant
- Remedi Co., Ltd. KR
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2024-05-13
- Date received
- 2024-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240759
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.