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Instrumentarium Corp.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K022630MODIFICATION TO FOCUSOctober 9, 2002
K001729FOCUSJuly 13, 2000
K001439ORTHOCEPH OC100 DJune 22, 2000
K992385ORTHOPANTOMOGRAPH OP100DSeptember 28, 1999
K981641MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQJuly 17, 1998
K962638TONOCAP, TC-200 AND ACCESSORY CATHETERSApril 4, 1997
K961441TONOMETERED SLAINE BLOOD GAS CONTROLApril 30, 1996
K955018TRIP NGS & SIGMOID CATHETER PHI SLIDE CALCULATORJanuary 30, 1996
K934478ALPHA STEREOJanuary 31, 1995
K923433AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULEJuly 22, 1993
K930338ORTHOCEPH OC100April 27, 1993
K912893ORTHOPANTOMOGRAPH 100November 5, 1991
K904355CARDIOCAP II TM CH-RESP MONITORSMay 23, 1991
K883621INSTRUMENTARIUM ULF MR IMAGING SYSTEMNovember 10, 1988
K883649INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110HOctober 19, 1988
K883650INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110September 16, 1988
K883622INSTRUMENTARIUM ULF MR IMAGING SYSTEMSeptember 14, 1988
K853953CARDIOCAP MONITORJune 2, 1986
K853396MULTICAP MULTIGAS CAPNOMETER PB252August 16, 1985
K833739CD-102 CARBON DIOXIDE ANALYZER/RECORDecember 16, 1983