ClearanceBrief
510(k) K080954 ยท FRN Pump, Infusion

T34L SYRINGE DRIVER

ApplicantCaesarea Medical Electronics , Ltd., Caesarea, IL
DecisionSubstantially Equivalent, May 16, 2008
ReceivedApr 3, 2008
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K080954

DateFirm and productCodeLinked 510(k)
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump -T34L - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r
Terminated		 FRNNone listed
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - NeoThrive - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accept
Terminated		 FRNNone listed
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - T34L PCA - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically accepta
Terminated		 FRNNone listed
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - Neofeed - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptab
Terminated		 FRNNone listed
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through c
Terminated		 FRNNone listed
Jul 30, 2020CME America, LLC
CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable r
Terminated		 FRNNone listed

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