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Biochem International, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
28
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K920083BIOCHEM MODEL 3302 NEWOX2 OXIMETERApril 11, 1994
K9323898100 ANESTHETIC AGENT MONITORDecember 3, 1993
K921388BIOCHEM 9100 MULTIGAS MONITOR IBP MODULEMay 26, 1993
K920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERJanuary 7, 1993
K911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBPAugust 22, 1991
K910381BIOCHEM TEMPERATURE/ FIO2 MODULEAugust 22, 1991
K903222BIOCHEM 6100 NON-INVASIVE MONITORSeptember 4, 1990
K901861BIOCHEM 9100 MULTIGAS MONITORJuly 27, 1990
K893877BIOCHEM 3100 OXIMETERDecember 20, 1989
K892646BIOCHEM 8100 ANESTHETIC AGENT MONITORAugust 31, 1989
K890874BIOCHEM 520 BREATH INDICATORJune 15, 1989
K873856BIOCHEM 9090 CAPNOGRAPH/SAO2December 17, 1987
K873959BIOCHEM 8800 CAPNOMETERDecember 11, 1987
K871133BIOCHEM 8090 CAPNOGRAPHApril 21, 1987
K870163BIOCHEM MICROSPAN 1040 OXIMETERMarch 3, 1987
K863186BIOCHEM CO/OX 1000November 7, 1986
K854333BIOCHEM 515 RESPIRATION MONITORMay 30, 1986
K842303MICROSPAN -PH MONITOROctober 12, 1984
K840918MICRO SPAN TRANSCUTANEOUS OXYGEN MONITApril 17, 1984
K812643LIFESPAN CO2November 16, 1981