FDA Registration
Active
🇨🇷 Costa Rica
Capnostat 5 Mainstream CO2 Sensor
Reg #: 3009490946
·
FEI: 3009490946
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Volcano Corporation by Volcarica S.R.L.
- Registration Number
- 3009490946
- FEI Number
- 3009490946
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Coyol Free Zone and Business Park, Building B37
- City
- Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K042601
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 2939520
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Megan Olen
- Address
- 9965 Federal Drive
- City
- Colorado Springs
- State
- CO
- ZIP
- 80921
- Country
- US
- [email protected]
- Phone
- 719 4472592
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2020-04-16 |
Proprietary Names
Capnostat 5 Mainstream CO2 Sensor
Capnography Sensor, Reusable
Establishment Types
Manufacture Medical Device