510(k) K970460 ยท CBK Ventilator, Continuous, Facility Use
NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)
| Applicant | Puritan Bennett Corp., Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 30, 1998 |
| Received | Feb 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970460
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Puritan Bennett 840 Ventilator (4-840120DIUU-XX)
The PB840 Ventilator System is intended to provide invasive or non-invasive ventilatory support and monitoring for infant, pediatric, and adult patien Terminated |
CBK | None listed |
| Jun 17, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part Terminated |
CBK | None listed |
| Jan 24, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02
The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient Terminated |
CBK | None listed |
| Jan 24, 2014 | Nellcor Puritan Bennett Inc. (dba Covidien LP) Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389
The intended use of the oxygen senso Terminated |
CBK | None listed |
| Jan 3, 2014 | Covidien Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG.
The intended use of the product is to provide mechanical ventilation to patients. Terminated |
CBK | None listed |
| Sep 16, 2008 | Covidien Limited Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA Terminated |
CBK | None listed |
| Apr 24, 2007 | Nellcor Puritan Bennett Puritan Bennett 840 Ventilator System, Catalogue Numbers:
4-84O12OXXXX-XX, 4-840220XXXX-XX, 4-NPB84O-XX, DL4-NPB84O-XX, DS4-NPB840-XX & 4-070550-SP
(Note: the Xs indicate any combination of alpha cha Terminated |
CBK | None listed |
| Aug 6, 2005 | Puritan Bennett Puritan Bennett 840 Series Ventilator Power Supply
Model/Catalog Numbers: 4-076314-00; 4-076314-SP Terminated |
CBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.