Respironics Novametrix, LLC.
Andover, MA, US
RESPIRONICS NOVAMETRIX, LLC appears in FDA device records in Andover, MA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Respironics Novametrix, LLC. between 2003 and 2011. The busiest year on record is 2004, with 5. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 5 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103578 | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST | BZK | Substantially Equivalent | |
| K092217 | MERCURY VCO2 | BZK | Substantially Equivalent | |
| K091459 | PHILIPS NM3 MONITOR, MODEL 7900 | BZK | Substantially Equivalent | |
| K080652 | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 | BZK | Substantially Equivalent | |
| K053174 | LOFLO C5 CO2 SENSOR | CCK | Substantially Equivalent | |
| K042601 | CAPNOSTAT 5 | CCK | Substantially Equivalent | |
| K032971 | TIDAL WAVE SP MODEL 710/715 AND 715 | DQA | Substantially Equivalent | |
| K032949 | SPOT CHECK PULSE OXIMETER,512/513 | DQA | Substantially Equivalent | |
| K041450 | MODIFICATION TO NICO WITH MARS, MODEL 7300 | CCK | Substantially Equivalent | |
| K032755 | MODEL 509M PULSE OXIMETER, MODEL 509M | DQA | Substantially Equivalent | |
| K030886 | NICO WITH MARS, MODEL 7300 | CCK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219324 | 1219324 | RESPIRONICS NOVAMETRIX, LLC | 3000 Minuteman Rd., Andover, MA 01810 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CATCannula, Nasal, Oxygen
- DQKComputer, Diagnostic, Programmable
- BZAConnector, Airway (Extension)
- DSIDetector And Alarm, Arrhythmia
- DPSElectrocardiograph
- GWQFull-Montage Standard Electroencephalograph
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- DQAOximeter
- DSBPlethysmograph, Impedance
- BZKSpirometer, Monitoring (W/Wo Alarm)
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- BXPTransducer, Gas Flow
- CBKVentilator, Continuous, Facility Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3288-2011 | FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 | Pressure lines maybe occluded and display incorrect tidal volumes. | Terminated | ||
| Z-3287-2011 | PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate. | Pressure lines maybe occluded and display incorrect tidal volumes. | Terminated | ||
| Z-2168-2011 | Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. | Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual. | Terminated | ||
| Z-2167-2011 | Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English - P/N 1051674 PHILIPS NM3 Monitor, English Refurbished - P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit - P/N DU1051674 PHILIPS NM3 Monitor, Spanish - P/N 1060462 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. | Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual. | Terminated | ||
| Z-1535-06 | NICO Model 7300 Cardiopulmonary Management System | Audible alarm may not sound during an alert condition | Terminated | ||
| Z-1049-04 | Model 509M Pulse Oximetry Interface Module Software versions 2.0 or 2.5 | Audio alarm may fail to sound when SpO2 limits drop below the set limits | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain