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Criticare Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
22
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K101602VITAL SIGNS MONITORSeptember 1, 2010
K091050506CN PATIENT MONITORMay 27, 2009
K0425698600 VITAL SIGNS MONITORSeptember 29, 2004
K030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100April 17, 2003
K022435507EL VITAL SIGNS MONITORAugust 14, 2002
K0120598100/8500 VITAL SIGNS MONITORAugust 1, 2001
K0010208100 VITAL SIGNS MONITORApril 28, 2000
K000276MPT 24 AND VITAL VIEW 24March 1, 2000
K961223MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMSDecember 10, 1996
K944860SCHOLAR PATIENT MONITORJune 20, 1995
K942737POET IQ WITH FIVE AGENT CAPABILITYFebruary 9, 1995
K921309MODEL 508 PATIENT MONITORDecember 17, 1993
K910852507 NON-INVASIVE VITAL SIGNS MONITORJuly 30, 1991
K911124503 PULSE OXIMETERJune 7, 1991
K910770504US PULSE OXIMETERMay 14, 1991
K8846431100 VITAL SIGNS MONITOROctober 30, 1989
K892854ANESTHETIC AGENT MONITOROctober 13, 1989
K884216506 NON-INVASIVE VITAL SIGNS MONITORMarch 16, 1989
K875298502-US PULSE OXIMETERMarch 7, 1988
K864745POET OXIMETERJune 2, 1987