FDA Registration
Active
🇺🇸 United States
M5070A Primary Battery
Reg #: 3012607778
·
FEI: 3012607778
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 3012607778
- FEI Number
- 3012607778
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 15100 Woodinville-Redmond Road NE, Bldg A, Suite 300
- City
- Woodinville
- State
- WA
- ZIP
- 98072
- Country
- US
Regulatory Submissions
- PMA Number
- P180028
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 |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2020-05-21 |
Proprietary Names
M5070A Primary Battery
989803139301 Aviation FRx Battery
861304 HeartStart FRx Defibrillator
989803139261 SMART Pads II
989803139311 Infant/Child Key
Establishment Types
Manufacture Medical Device