Instromedix, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K010945HEARTCARD, MODEL 5258June 12, 2001
K964408POSEIDON CARDIAC MONITORING SYSTEM (PCMS)July 23, 1997
K964036CARDIOMAGIC 2000 SOFTWAREJuly 18, 1997
K955060ACCELERATED TRANSMISSION PROTOCOLApril 8, 1996
K951096LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVERJanuary 16, 1996
K945476HEARTHWATCH III(TM)November 9, 1995
K950003CARDIOMAGIC(R) SOFTWARE ENHANCEMENTSOctober 31, 1995
K944362HEARTCARD CARDIAC EVENT MONITORSeptember 7, 1995
K943931CARRYALL ENHANCEMENTSApril 4, 1995
K935586PRINCENovember 8, 1994
K925639CARDIOMAGIC SOFTWAREJune 22, 1993
K923221KING OF HEARTS SCEPTERMarch 8, 1993
K925809COMPRESSAR UNIVERSAL (TM) SYSTEMFebruary 22, 1993
K920984KING OF HEARTS EXPRESS (E.X.) MONITOROctober 14, 1992
K896040KING OF HEARTS CDMMay 15, 1990
K896039KING OF HEARTS 1200 MONITORFebruary 28, 1990
K896002CARRY-ALL EKG TRANSTELEPHONIC TRANSMITTERJanuary 19, 1990
K891000MODIFIED EXTERNAL PADMay 19, 1989
K881297BARO-GRAF 24September 16, 1988
K880626KING OF HEARTSApril 11, 1988