FDA Registration
Active
🇺🇸 United States
Sidestream Reusable Neb and Masks
Reg #: 3002797442
·
FEI: 3002797442
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RESPIRONICS, INC.
- Registration Number
- 3002797442
- FEI Number
- 3002797442
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 174 Tech Center Drive
- City
- Mount Pleasant
- State
- PA
- ZIP
- 15666
- Country
- US
Regulatory Submissions
- 510(k) Number
- K991725
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 2518422
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 1999-11-01 |
Proprietary Names
Sidestream Reusable Neb and Masks
Establishment Types
Repack or Relabel Medical Device