510(k) K083526 ยท CBK Ventilator, Continuous, Facility Use
TRILOGY 100 VENTILATOR
| Applicant | Respironics Inc., Sleep & Home Respiratory Group, Murrysville PA, US |
| Decision | Substantially Equivalent, Mar 13, 2009 |
| Received | Nov 28, 2008 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K083526
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2023 | Philips Respironics, Inc. Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU10 Open, Classified |
CBK | None listed |
| Jan 6, 2023 | Philips Respironics, Inc. Philips Garbin Ventilator, Model Number 1058180B Open, Classified |
CBK | None listed |
| Jul 15, 2021 | Philips Respironics, Inc. Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. Open, Classified |
CBK | None listed |
| Mar 7, 2016 | Philips 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 |
CBK | None listed |
| Mar 6, 2014 | Phillips 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 |
CBK | None listed |
| Jul 23, 2012 | Respironics, 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 |
CBK | None listed |
| Jan 11, 2012 | Respironics, Inc. Trilogy 100, 200 and 202 Ventilators
The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and Terminated |
CBK | None listed |
| Jun 24, 2010 | Respironics, Inc. Trilogy 100 Ventilator, Model/Catalog Number 1054260, U1054260 (Domestic). Philips Respironics, Monroeville, PA 15146.
Provides continuous or intermittent ventilatory support for the care of individ Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.