BTY · Class II · 21 CFR 868.1890

FDA Product Code BTY: Calculator, Predicted Values, Pulmonary Function

Leading manufacturers include Viasys Healthcare GmbH, Carefusion Germany 234 GmbH and Eresearchtechnology GmbH.

64
Total
64
Cleared
159d
Avg days
1978
Since
64 devices
25–48 of 64
Cleared Dec 14, 2000
METALYZER, MODEL 2
K993641
Cortex Biophysik GmbH
Anesthesiology · 413d
Cleared Mar 29, 2000
SPIRO PRO
K000648
Erich Jaeger GmbH
Anesthesiology · 30d
Cleared Oct 30, 1998
STATIC AND DYNAMIC COMPLIANCE, A RESPIRATORY MECHANICS OPTION FOR THE VMAX SERIES
K981366
Sensor Medics Corp.
Anesthesiology · 198d
Cleared Jul 28, 1998
MODIFICATION TO THE OXYCONALPHA
K980094
Erich Jaeger B.V.
Anesthesiology · 200d
Cleared Feb 14, 1997
DSXL DIFFUSION SPIROMETER
K961252
Inair , Ltd.
Anesthesiology · 319d
Cleared Nov 22, 1994
VMAX229 SERIES PULMONARY/METABOLIC SYSTEMS
K942211
Sensor Medics Corp.
Anesthesiology · 201d
Cleared Mar 07, 1994
FLOWSCREEN
K932744
Erich Jaeger, Inc.
Anesthesiology · 272d
Cleared Mar 07, 1994
MASTER SCREEN PNUEMO
K933839
Erich Jaeger, Inc.
Anesthesiology · 214d
Cleared Feb 10, 1994
UPGRADED SPIROMETER ST-90
K933511
Futuremed Div. of Future Impex Corp.
Anesthesiology · 210d
Cleared Dec 17, 1993
MODEL 508 PATIENT MONITOR
K921309
Criticare Systems, Inc.
Anesthesiology · 647d
Cleared Jul 26, 1993
VITALOGRAPH DATA STORAGE SPIROMETER
K930085
Vitalograph , Ltd.
Anesthesiology · 200d
Cleared Mar 06, 1987
L.A.P. SPIROMETER
K864836
Timeter Instrument Corp.
Anesthesiology · 87d
Cleared May 19, 1986
SPIROMETRY MODULE
K861486
Medical Graphics Corp.
Anesthesiology · 27d
Cleared Jan 21, 1983
VITALOGRAPH PFT PRINTER
K823683
Vitalograph , Ltd.
Anesthesiology · 45d
Cleared Nov 27, 1981
PFT SCREENER (SYSTEM 1100)
K812792
Medical Graphics Corp.
Anesthesiology · 52d
Cleared Mar 24, 1981
ELECTRONIC SPIROMETER MODEL MFR-8100
K810712
Nihon Kohden America, Inc.
Anesthesiology · 7d