ClearanceBrief
510(k) K080652 ยท BZK Spirometer, Monitoring (W/Wo Alarm)

MERCURY VCO2 MODULE WITH CAPNOSTAT 5

ApplicantRespironics Novametrix, LLC, Wallingford CT, US
DecisionSubstantially Equivalent, Jun 20, 2008
ReceivedMar 7, 2008
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K080652

DateFirm and productCodeLinked 510(k)
Sep 30, 2011Respironics Novametrix, LLC.
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 N
Terminated
BZKNone listed
Sep 30, 2011Respironics Novametrix, LLC.
FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
Terminated
BZKNone listed
May 10, 2011Respironics Novametrix, LLC.
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
Terminated
None listed
May 10, 2011Respironics Novametrix, LLC.
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 calculation
Terminated
None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.