FDA Registration
Active
🇺🇸 United States
SANTA BARBARA IMAGING SYSTEMS
Reg #: 3011373951
·
FEI: 3011373951
·
Expires 2026
Products
12
Proprietary Names
0
Establishment Types
4
Classifications
12
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Registration Details
- Registration Name
- SANTA BARBARA IMAGING SYSTEMS
- Registration Number
- 3011373951
- FEI Number
- 3011373951
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 340 Storke Rd Ste 101
- City
- Goleta
- State
- CA
- ZIP
- 93117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152513
Owner / Operator
- Firm Name
- Santa Barbara Imaging Systems
- Operator Number
- 10048981
- Address
- 340 Storke Road, Suite 101
- City
- Goleta
- State
- CA
- Postal Code
- 93117
- Country
- US
- Correspondent
- Nathanael Sommer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2018-08-07 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2017-04-18 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2018-08-07 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2018-08-07 |
| Accessory Equipment, Cardiopulmonary Bypass | KRI | Class 1 | Cardiovascular | No | 2018-11-15 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2018-08-07 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2018-08-07 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2018-08-07 |
| Camera, Television, Surgical, With Audio | FWC | Class 1 | General, Plastic Surgery | No | 2015-03-27 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2018-08-07 |
| Light, Surgical, Fiberoptic | FST | Class 2 | General, Plastic Surgery | No | 2018-08-07 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2018-08-07 |
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)