FDA Registration
Active
🇺🇸 United States
ID-Cap System
Reg #: 3018229258
·
FEI: 3018229258
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ETECTRX, INC.
- Registration Number
- 3018229258
- FEI Number
- 3018229258
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 747 SW 2nd Avenue, Suite 365T, IMB 24
- City
- Gainesville
- State
- FL
- ZIP
- 32601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183052
Owner / Operator
- Firm Name
- etectRx, Inc.
- Operator Number
- 10081038
- Address
- 747 SW 2nd Avenue, Suite 365T, IMB 24
- City
- Gainesville
- State
- FL
- Postal Code
- 32601
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ingestible Event Marker | OZW | Class 2 | General Hospital | No | 2021-03-12 |
Proprietary Names
ID-Cap System
Establishment Types
Manufacture Medical Device