FDA Registration
Active
🇺🇸 United States
13943B Solid Gel Tab Electrode, Resting ECG
Reg #: 3016618143
·
FEI: 3016618143
·
Expires 2025
Products
1
Proprietary Names
1
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
- K904185
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 |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2009-02-19 |
Proprietary Names
13943B Solid Gel Tab Electrode, Resting ECG
Establishment Types
Repack or Relabel Medical Device