FDA Registration
Active
🇺🇸 United States
Servo Wall Mount Infant Warmer Wall mount bracket Manual Wall Mount Infant Warmer Wall Mount Infant Warmer
Reg #: 2085602
·
FEI: 3000210616
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FISHER & PAYKEL HEALTHCARE, INC.
- Registration Number
- 2085602
- FEI Number
- 3000210616
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 17400 Laguna Canyon Road, #300
- City
- IRVINE
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K972885
Owner / Operator
- Firm Name
- FISHER & PAYKEL HEALTHCARE NZ LTD
- Operator Number
- 8040217
- Address
- 15 MAURICE PAYKEL PLACE
- City
- EAST TAMAKI, AUCKLAND
- State
- NZ-NOTA
- Postal Code
- 2013
- Country
- NZ
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Warmer, Infant Radiant | FMT | Class 2 | General Hospital | No | 2007-12-02 |
Proprietary Names
Servo Wall Mount Infant Warmer Wall mount bracket Manual Wall Mount Infant Warmer Wall Mount Infant Warmer
Establishment Types
Complaint File Establishment per 21 CFR 820.198