FDA Registration
Active
🇺🇸 United States
RESPIRONICS, INC.
Reg #: 3007220521
·
FEI: 3007220521
·
Expires 2026
Products
5
Proprietary Names
43
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- RESPIRONICS, INC.
- Registration Number
- 3007220521
- FEI Number
- 3007220521
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 312 Alvin Drive
- City
- New Kensington
- State
- PA
- ZIP
- 15068
- Country
- US
Regulatory Submissions
- 510(k) Number
- K111885
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 |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2012-01-17 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2012-01-17 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2011-10-25 |
| Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | BZE | Class 2 | Anesthesiology | No | 2020-09-14 |
| Ventilator, Continuous, Non-Life-Supporting | MNS | Class 2 | Anesthesiology | No | 2010-08-05 |
Proprietary Names
SimplyGo POC
SimplyFlo POC
SimplyGo Mini POC
REMstar/BiPAP Q-Series w/HT
BiPAP Q-Series w/HT
REMstar Q-series CPAP w/HT
DreamStation Link Module (RIST)
Payer Integration Software (RIMR)
Omnilab Conncect (RIMR)
AOM (RIMR)
Sleepmapper (RIMR)
DreamStation Wi-Fi Accessory (RIST)
HL7 Interface Utility (RIMR)
DreamStation Cellular Modem (RIST)
PR1 Wired/Wireless Modems (RIST)
DreamMapper
REMstar Q-Series CPAP
EncoreAnywhere
BiPAP Q-Series
REMstar SE CPAP
Dorma CPAP
Universal Battery Pack (UBP2)
Dreamstation 2 Advanced System
Dreamstation 2 System
PC Direct
Omnilab Direct
Omnilab Advanced/Advanced +
BiPAP autoSV Advanced
System One BiPAP w/ & w/o Humidifier
DreamStation BiPAP autoSV w/ & w/o Humidifier
DreamStation BiPAP S/T w/ & w/o Humidifier
DreamStation BiPAP AVAPS w/ & w/o Humidifier
DreamStation BiPAP Auto w/ & w/o Humidifier
Dreamstation CPAP Auto w/ & w/o Humidifier
REMstar Auto A-flex HT (Q-series)
DreamStation CPAP w/ & w/o Humidifier
Dreamstation CPAP Pro w/ & w/o Humidifier
DreamStation BiPAP Pro w/ & w/o Humidifier
DreamStation Go CPAP
DreamStation Go Auto CPAP
Dreamstation GO w/ & w/o Humidifier
DreamStation CPAP Assist
BiPAP AVAPS or S/T C-Series
Establishment Types
Manufacture Medical Device