FDA Registration
Active
🇺🇸 United States
989803160301 Microstream® EtCO2 Consumables Smart CapnoLine Plus Long
Reg #: 1218950
·
FEI: 1218950
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips North America LLC
- Registration Number
- 1218950
- FEI Number
- 1218950
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3000 Minuteman Rd
- City
- ANDOVER
- State
- MA
- ZIP
- 01810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K011050
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 |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2017-03-31 |
Proprietary Names
989803160301 Microstream® EtCO2 Consumables Smart CapnoLine Plus Long
Establishment Types
Complaint File Establishment per 21 CFR 820.198