FDA Registration
Active
🇺🇸 United States
PageWriter TC50 Cardiograph, TC50 (860310, 860429, 860466)
Reg #: 3016618143
·
FEI: 3016618143
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 3016618143
- FEI Number
- 3016618143
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 222 Jacobs Street
- City
- Cambridge
- State
- MA
- ZIP
- 02141
- Country
- US
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
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