K234096
- 510(k) number
- K234096
- Device name
- MonoStereo
- Applicant
- Medicaltek Co., Ltd. TW
- Product code
- EOB — Nasopharyngoscope (Flexible Or Rigid)
- Decision date
- 2024-09-19
- Date received
- 2023-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K234096
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.