FDA Registration
Active
🇺🇸 United States
ZAP-X Radiosurgery System
Reg #: 3012039133
·
FEI: 3012039133
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ZAP SURGICAL SYSTEMS INC.
- Registration Number
- 3012039133
- FEI Number
- 3012039133
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 590 Taylor Way
- City
- San Carlos
- State
- CA
- ZIP
- 94070
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211663
Owner / Operator
- Firm Name
- Zap Surgical Systems Inc.
- Operator Number
- 10058325
- Address
- 590 Taylor Way
- City
- San Carlos
- State
- CA
- Postal Code
- 94070
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2023-07-06 |
Proprietary Names
ZAP-X Radiosurgery System
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198