ClearanceBrief
510(k) K093416 ยท CBK Ventilator, Continuous, Facility Use

TRILOGY 200 VENTILATOR

ApplicantRespironics, Inc., Murrysville PA, US
DecisionSubstantially Equivalent, Jan 29, 2010
ReceivedNov 2, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K093416

DateFirm and productCodeLinked 510(k)
Jan 6, 2023Philips Respironics, Inc.
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
Open, Classified
CBKNone listed
Jul 15, 2021Philips Respironics, Inc.
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators.
Open, Classified
CBKNone listed
Mar 7, 2016Philips Respironics
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus provides continuous or intermittent ventilatory support for the care o
Terminated
CBKNone listed
Mar 6, 2014Phillips Respironics, Inc.
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilator support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended fo
Terminated
CBKNone listed
Jul 23, 2012Respironics, Inc.
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilatio
Terminated
CBKNone listed

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