FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
MonoStereo
K Number: K234096
·
Decision Sep 19, 2024
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
161
Applicant Total
1
Review Days
268
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Basic Information
- Device Name
- MonoStereo
- K Number
- K234096
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4760
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medicaltek Co., Ltd.
- Date Received
- December 26, 2023
- Decision Date
- September 19, 2024
- Product Code
- EOB
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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