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Burdick Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
44
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K952417QUEST EXERCISE STRESS SYSTEMMay 22, 1996
K954267BURDICK 200 PULSE OXIMETERMay 3, 1996
K946281ECLIPSE 4 ELECTROCARDIOGRAPHApril 23, 1996
K945985PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400July 3, 1995
K943959ECLIPSE 4 ELECTROCARDIOGRAPHMay 17, 1995
K942565ALTAIR-DISC RECORDERDecember 5, 1994
K941351BURDICK PRO2 OXIMETEROctober 13, 1994
K942438ALTAIR 6100 CASSETTE RECORDERAugust 5, 1994
K904032ELITE II ELECTROCARDIOGRAPHJuly 24, 1991
K903565E560 ELECTROCARDIOGRAPHJuly 24, 1991
K900729NEOSERV 824June 8, 1990
K885085ERGOMED 840/ERGOMED 840LOctober 3, 1989
K892835E350 ELECTROCARDIOGRAPHJune 1, 1989
K883440E550 ELECTROCARDIOGRAPHJanuary 17, 1989
K873774M300 MONITOR/CONTROLLER T500 TREADMILLNovember 6, 1987
K870920ELITE ELECTROCARDIOGRAPHApril 13, 1987
K870880EK10 ELECTROCARDIOGRAPHApril 9, 1987
K852250595 ARRHYTHMIA MONITORING SYSTEMMay 2, 1986
K842944MONITORING SYSTEM M720March 1, 1985
K844665COMPUTERFebruary 13, 1985