510(k) K234096
K234096 is an FDA 510(k) premarket notification submitted by Medicaltek Co., Ltd. for the device "MonoStereo". The FDA issued a decision of Substantially Equivalent on September 19, 2024. The device falls under product code EOB (Nasopharyngoscope (Flexible Or Rigid)), a Class II device regulated under 21 CFR 874.4760.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 19, 2024
- Date Received
- December 26, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nasopharyngoscope (Flexible Or Rigid)
- Device Class
- Class II
- Regulation Number
- 874.4760
- Review Panel
- EN
- Submission Type
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).