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Spirometrics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K915059PEAK FLOW MONITORJuly 27, 1992
K911358CMD/DLCO DIAGNOSTIC SPIROMETERJuly 22, 1991
K900322CO/CMD-1April 30, 1990
K900673SERIAL FLOWApril 3, 1990
K901057SPIROMETRICS MODEL 2600 MIRO SPIROMETERApril 3, 1990
K884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSORJanuary 19, 1989
K884465SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)November 9, 1988
K863953SPIROMETRICS MODEL 2500 FLOWMATE(TM)January 15, 1987
K850045SPIROMETRICS 2453 & SMI IIIFebruary 14, 1985
K844333SPIROMETRICS 2451 & SMI INovember 20, 1984
K831497SPIROMETRICS BREON 2400 & SMI 2400June 24, 1983