Katecho, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
26
Inspections
7
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K012404K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85October 12, 2001
K010543KM-30 TENS ELECTRODEMay 23, 2001
K003228K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70ADecember 14, 2000
K002806K-DEFIB/PACE, MODEL KDP-60ANovember 21, 2000
K000870KM-10 TENS ELECTRODENovember 7, 2000
K993745K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80February 3, 2000
K991007K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60August 23, 1999
K981737K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60December 9, 1998
K954504K-DEFIB/PACE PEDIATRIC ELECTRODENovember 17, 1995
K934692K-DEFIB/PACE PEDIATRIC ELECTRODEJanuary 24, 1995
K940801K-KLIPAugust 3, 1994
K935083PEDIATRIC DEFIB K-PADSJuly 25, 1994
K940586K-SNAPJune 9, 1994
K922202K-STIM CLEARMay 17, 1993
K926175K-DEFIB/PACE CARBON ELECTRODEApril 15, 1993
K921679K-DISPERSEOctober 6, 1992
K915328GEL-TACJune 29, 1992
K914955K-DEFIB/PACE ELECTRODEMay 14, 1992
K912381LOW BACK STRIP (OR) K-BACKJanuary 30, 1992
K913031K-STIMJanuary 30, 1992