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Protocol Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K002725MICROPAQ, MODELS 402 AND 404November 21, 2000
K972121ACUITY CENTRAL STATIONNovember 7, 1997
K951246PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONSFebruary 2, 1996
K945071PROPAQ 200 MONITORMay 10, 1995
K935846MODEL ACUITY CENTRAL STATIONDecember 5, 1994
K934711PROPAQ ECG TELEMETRY OPTIONSeptember 1, 1994
K921497PROPAQ MONITORS, MODIFICATIONMarch 23, 1993
K914838PROPAQ 102,104,106,102EL,104EL,&106ELJanuary 10, 1992
K913193MODEL 100 CENTRAL STATIONOctober 16, 1991
K910882PROPAQ 102EL, 104EL AND 106ELMay 8, 1991
K910772PROPAQ 102, 104 AND 106April 12, 1991
K902730SPO2 OPTIONOctober 22, 1990
K894607PAQ10 PAPER CHART RECORDEROctober 26, 1989
K884320PROPAQ 106(TM)December 27, 1988
K882085PROPAQ 104(TM)July 28, 1988