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Hudson Respiratory Care, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K031383MODEL 780July 7, 2003
K011125NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCIJune 13, 2001
K011134OXYGEN SUPPLY TUBING, MODEL 1115June 13, 2001
K010402SMOOTH-FLO CIRCUITMarch 14, 2001
K001213CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60November 3, 2000
K993355HUDSON RCI CONCHA COLUMN, CAT. NO. 385-40 AND HUDSON RCI CIRCUIT, CAT. NO. 780-40, 780-41, 780-42, 7May 24, 2000
K994352SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896March 22, 2000
K964719HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATORFebruary 21, 1997
K961150DUAL LUMEN OXYGEN DELIVERY GAS SAMPLING CANNULASeptember 10, 1996
K961914BACTERIA/VIRAL FILTERAugust 14, 1996
K955645CATH-GUIDEMarch 12, 1996
K944301HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380December 21, 1994
K923946CONCHATHERM IV HEATED MOLECULAR HUMIDIFIEROctober 18, 1994
K930525MICRO MIST(TM) NEBULIZERSeptember 29, 1993
K903083NEONATAL VENTILATOR CIRCUITDecember 27, 1990