Medical Device Manufacturer · US , Mchenry , IL

Spirometrics, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1983

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Spirometrics, Inc. Anesthesiology ✕

10 devices

1-10 of 10

Cleared Jul 27, 1992

PEAK FLOW MONITOR

Anesthesiology · 262d

Cleared Jul 22, 1991

CMD/DLCO DIAGNOSTIC SPIROMETER

Anesthesiology · 116d

Cleared Apr 30, 1990

Anesthesiology · 97d

Cleared Apr 03, 1990

Anesthesiology · 49d

Cleared Apr 03, 1990

SPIROMETRICS MODEL 2600 MIRO SPIROMETER

Anesthesiology · 28d

Cleared Jan 19, 1989

SPIROMETRICS MODEL 2200 SM200 FLOW SENSOR

Anesthesiology · 87d

Cleared Jan 15, 1987

SPIROMETRICS MODEL 2500 FLOWMATE(TM)

Anesthesiology · 97d

Cleared Feb 14, 1985

SPIROMETRICS 2453 & SMI III

Anesthesiology · 38d

Cleared Nov 20, 1984

SPIROMETRICS 2451 & SMI I

Anesthesiology · 13d

Cleared Jun 24, 1983

SPIROMETRICS BREON 2400 & SMI 2400

Anesthesiology · 45d