ClearanceBrief
510(k) K131252 ยท CBK Ventilator, Continuous, Facility Use

PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM

ApplicantCovidien, Boulder CO, US
DecisionSubstantially Equivalent, Feb 24, 2014
ReceivedMay 2, 2013
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K131252

DateFirm and productCodeLinked 510(k)
Nov 21, 2017Covidien LLC
Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilator System including Pediatric-Adult Ventilator, Neonatal Ventilator, Universal Ventilator; Battery Product Number: 10086042;
Terminated		 CBKNone listed
Mar 17, 2016Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invas
Terminated		 CBKNone listed
Aug 14, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality enabled) and Neonatal Models. Designed for use on Neonatal (NICU) through Adult patient populations who require respirato
Terminated		 CBKNone listed
Feb 5, 2015Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations
Terminated		 CBKNone listed
Dec 9, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Terminated		 CBKNone listed
Oct 28, 2014Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU)
Terminated		 CBKNone listed

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