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Criticare Systems, Inc.

FDA Regulatory Profile

Criticare Systems, Inc. has 0 FDA recalls, 0 inspections, 22 510(k) clearances and 0 compliance actions on record.

Latest 510(k)
Sep 1, 2010

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances22Oct 4, 2026Not statedCurrent
Inspections0Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent 510(k) Clearances

K-NumberDeviceDate
K101602VITAL SIGNS MONITORSep 1, 2010
K091050506CN PATIENT MONITORMay 27, 2009
K0425698600 VITAL SIGNS MONITORSep 29, 2004
K030613VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100Apr 17, 2003
K022435507EL VITAL SIGNS MONITORAug 14, 2002
K0120598100/8500 VITAL SIGNS MONITORAug 1, 2001
K0010208100 VITAL SIGNS MONITORApr 28, 2000
K000276MPT 24 AND VITAL VIEW 24Mar 1, 2000
K961223MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMSDec 10, 1996
K944860SCHOLAR PATIENT MONITORJun 20, 1995
K942737POET IQ WITH FIVE AGENT CAPABILITYFeb 9, 1995
K921309MODEL 508 PATIENT MONITORDec 17, 1993
K910852507 NON-INVASIVE VITAL SIGNS MONITORJul 30, 1991
K911124503 PULSE OXIMETERJun 7, 1991
K910770504US PULSE OXIMETERMay 14, 1991
K8846431100 VITAL SIGNS MONITOROct 30, 1989
K892854ANESTHETIC AGENT MONITOROct 13, 1989
K884216506 NON-INVASIVE VITAL SIGNS MONITORMar 16, 1989
K875298502-US PULSE OXIMETERMar 7, 1988
K864745POET OXIMETERJun 2, 1987

FDA data resources