FDA Registration
Active
🇺🇸 United States
Sleepmapper (RIMR)
Reg #: 3007220521
·
FEI: 3007220521
·
Expires 2025
Products
1
Proprietary Names
11
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- RESPIRONICS, INC.
- Registration Number
- 3007220521
- FEI Number
- 3007220521
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 312 Alvin Drive
- City
- New Kensington
- State
- PA
- ZIP
- 15068
- Country
- US
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 |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-10-25 |
Proprietary Names
Sleepmapper (RIMR)
Payer Integration Software (RIMR)
DreamStation Cellular Modem (RIST)
AOM (RIMR)
PR1 Wired/Wireless Modems (RIST)
DreamStation Wi-Fi Accessory (RIST)
DreamStation Link Module (RIST)
Omnilab Conncect (RIMR)
Encore Basic (RIMR)
HL7 Interface Utility (RIMR)
DreamMapper
Establishment Types
Manufacture Medical Device