FDA Registration
Active
🇺🇸 United States
Sampling Line Male Luer-lok Adapter Dehumidification
Reg #: 1219324
·
FEI: 1219324
·
Expires 2025
Products
10
Proprietary Names
15
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- RESPIRONICS NOVAMETRIX, LLC
- Registration Number
- 1219324
- FEI Number
- 1219324
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3000 Minuteman Rd.
- City
- Andover
- State
- MA
- ZIP
- 01810
- Country
- US
Regulatory Submissions
- 510(k) Number
- K083750
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2016-03-31 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2016-03-31 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2016-03-31 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2016-03-31 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2016-03-31 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2016-03-31 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2016-03-31 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2016-03-31 |
| Full-Montage Standard Electroencephalograph | GWQ | Class 2 | Neurology | No | 2016-03-31 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2016-03-31 |
Proprietary Names
Sampling Line Male Luer-lok Adapter Dehumidification
Airway Adapter Pediatric/Infant Nafion Capnoflex
Airway Adapter Adult/Pediatric Capnoflex
Cannula Nasal CO2 Only Pediatric Capnoflex
Cannula Nasal CO2 Adult Capnoflex
Infant/Neonatal Airway Adapter Kit Capnoflex
Pediatric Nasal/Oral CO2 Cannula Capnoflex
Pediatric Nasal CO2/O2 Cannula Capnoflex
Sample Line Male Luer Capnoflex
Airway Adapter Adult/Pediatric Nafion Capnoflex
Adult Nasal/Oral CO2 Cannula Capnoflex
Infant Nasal CO2 Cannula Capnoflex
Infant Nasal CO2/O2 Cannula
Cannula Oral/Nasal CO2/O2 Adult Capnoflex D
Cannula Nasal CO2/O2 Adult Capnoflex
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility