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Nellcor Puritan Bennett, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
43
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K070899PURITAN BENNETT LEGENDAIR XL2December 13, 2007
K070408DURAMAX REUSABLE OXIMETRY SENSORMay 25, 2007
K060576NELLCOR OXIMAX N-600X PULSE OXIMETERAugust 14, 2006
K051271OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSORJanuary 10, 2006
K052186NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-PNovember 10, 2005
K051352OXIMAX NPB-40 HANDHELD PULSE OXIMETERAugust 11, 2005
K050072GOODKNIGHT 425STJune 13, 2005
K033973OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSORDecember 13, 2004
K030787SHILEY FLEXTRA TRACHEOSTOMY TUBENovember 14, 2003
K030930OXIMAX SOFTCARE SENSORS, MODELS SC-A, SC-PR, SC-NEO, SC-NMay 23, 2003
K023494NELLCOR INDGO MANUAL RESUSCITATORFebruary 7, 2003
K022819NELLCOR N-200 PULSE OXIMETER, MODEL N-200September 24, 2002
K020357800 SERIES EASYNEB NEBULIZERAugust 7, 2002
K021089OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSORJune 19, 2002
K021090OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETERMay 8, 2002
K020604WARMTOUCH PATIENT WARMING SYSTEM, MODEL 5300April 23, 2002
K012891OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIEMarch 7, 2002
K014121WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860January 11, 2002
K002686ACHIEVA VENTILATOR Y-ACH+E, ACHIEVA PS VENTILATOR Y-ACHPS+E, ACHIEVA PSO2 VENTILATOR Y-ACHPS02+EOctober 18, 2000
K993637N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMSNovember 24, 1999