Hans Rudolph, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K071149HRI 6500, 6600 AND 6700 SERIES V2MASKSFebruary 1, 2008
K0308227600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKSJune 3, 2003
K030515HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKSMay 2, 2003
K0207597600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTAugust 13, 2002
K962848HANS RUDOLPH NASAL CPAP MASKOctober 16, 1996
K960401ULTIMATE SEALJune 20, 1996
K946077DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERSSeptember 15, 1995
K945894MASK, GAS, ANESTHETICJanuary 27, 1995
K933583NONREBREATHING VALVEJanuary 3, 1994
K932147NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONEAugust 20, 1993
K7917054200 PNEUMATIC MOUTH SHUTTEROctober 4, 1979