FDA Registration
Active
🇨🇳 China
PMD Pulse Oximeter
Reg #: 3007583504
·
FEI: 3007583504
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Sanbor Medical Xiamen, Inc.
- Registration Number
- 3007583504
- FEI Number
- 3007583504
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1776 Lv Ling Road
- City
- Xiamen Fujian
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K141362
Owner / Operator
- Firm Name
- Sanbor Medical
- Operator Number
- 10028522
- Address
- 7584 Morris Court, Suite 218
- City
- Allentown
- State
- PA
- Postal Code
- 18106
- Country
- US
- Correspondent
- Wayne Meng
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-05-07 |
Proprietary Names
PMD Pulse Oximeter
Establishment Types
Repack or Relabel Medical Device