FDA Registration
Active
🇨🇳 China
PageWriter TC50 Cardiograph, TC50 (860310, 860429, 860466)
Reg #: 3012027770
·
FEI: 3012027770
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips Healthcare - Shanghai CDC
- Registration Number
- 3012027770
- FEI Number
- 3012027770
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building A2, #718 Lingshi Road, JingAn District
- City
- SHANGHAI
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210560
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Deborah Currlin
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
- [email protected]
- Phone
- 858 9452753
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2021-07-12 |
Proprietary Names
PageWriter TC50 Cardiograph, TC50 (860310, 860429, 860466)
PageWriter TC70 Cardiograph, TC70 (860315, 860352)
PageWriter TC30 Cardiograph, TC30 (860306)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility