Spirometrics, Inc.

FDA Regulatory Profile

Spirometrics, Inc. appears in FDA public data with 0 recalls, 11 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jul 27, 1992.

Summary

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

Recent 510(k) Clearances

K-NumberDeviceDate
K915059PEAK FLOW MONITORJul 27, 1992
K911358CMD/DLCO DIAGNOSTIC SPIROMETERJul 22, 1991
K900322CO/CMD-1Apr 30, 1990
K901057SPIROMETRICS MODEL 2600 MIRO SPIROMETERApr 3, 1990
K900673SERIAL FLOWApr 3, 1990
K884464SPIROMETRICS MODEL 2200 SM200 FLOW SENSORJan 19, 1989
K884465SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)Nov 9, 1988
K863953SPIROMETRICS MODEL 2500 FLOWMATE(TM)Jan 15, 1987
K850045SPIROMETRICS 2453 & SMI IIIFeb 14, 1985
K844333SPIROMETRICS 2451 & SMI INov 20, 1984
K831497SPIROMETRICS BREON 2400 & SMI 2400Jun 24, 1983