FDA Registration
Active
🇺🇸 United States
OtoSight Middle Ear Scope
Reg #: 1000261180
·
FEI: 1000261180
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GENTEX CORPORATION
- Registration Number
- 1000261180
- FEI Number
- 1000261180
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 600 North Centennial Street
- City
- Zeeland
- State
- MI
- ZIP
- 49464
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222655
Owner / Operator
- Firm Name
- Gentex Corporation
- Operator Number
- 10087496
- Address
- 600 North Centennial Street
- City
- Zeeland
- State
- MI
- Postal Code
- 49464
- Country
- US
- Correspondent
- Dave Newhouse
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Device System, Imaging, Tympanic Membrane And Middle Ear | QJG | Class 2 | Radiology | No | 2025-04-14 |
Proprietary Names
OtoSight Middle Ear Scope
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)