MonoStereo— 510(k) K234096
Substantially EquivalentMedicaltek Co., Ltd.
FDA 510(k) clearance K234096 for MonoStereo, Substantially Equivalent on 2024-09-19. Applicant: Medicaltek Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Medicaltek Co., Ltd.
- Product code
- Code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung City, TW
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Adverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.