Rondex Products, Inc.

FDA Regulatory Profile

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K981169RONDEX CPR ISO-SHIELDMay 19, 1998
K942671CPR SHIELDFebruary 7, 1995
K943761NON-BREATHING VALVENovember 10, 1994
K921002RONDEX MASK MODELS 9122/9111/9102/911102, MODIFIEDOctober 6, 1992
K914195RONDEX CPR NON REBREATHING VALVE #9030, MODIFIEDNovember 8, 1991
K914196RONDEX MASKS MODELS 9015/9011/901102 MODIFIEDNovember 8, 1991
K902299CPR VALVE (NON-REBREATHING) MODEL #9030October 26, 1990
K902298ORAL-NASAL MASK RESUSCITATION AND ANESTHETIC GASAugust 22, 1990
K881931RESCUE MASK & CPR VALVE FOR MOUTH-TO-MASK TYPE CPRJuly 21, 1988
K881393RONDEX RESCUE MASKApril 25, 1988
K834250RESCUE MASKJanuary 18, 1984