FDA Registration
Active
🇺🇸 United States
OSI OPTOELECTRONICS (MEDICAL DIVISION)
Reg #: 3006713849
·
FEI: 3006713849
·
Expires 2026
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- OSI OPTOELECTRONICS (MEDICAL DIVISION)
- Registration Number
- 3006713849
- FEI Number
- 3006713849
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12525 Chadron Ave
- City
- Hawthorne
- State
- CA
- ZIP
- 90250
- Country
- US
Regulatory Submissions
- 510(k) Number
- K033876
Owner / Operator
- Firm Name
- OSI Optoelectronics (Medical Division)
- Operator Number
- 10024288
- Address
- 12525 Chadron Ave
- City
- Hawthorne
- State
- CA
- Postal Code
- 90250
- Country
- US
- Correspondent
- Kevin Jardim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2010-07-06 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2015-07-10 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2025-12-17 |
| Oximeter, Ear | DPZ | Class 2 | Cardiovascular | No | 2015-07-10 |
Proprietary Names
Dolphin
Adroit Surgical
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)