BZG · Class II · 21 CFR 868.1840

FDA Product Code BZG: Spirometer, Diagnostic

Leading manufacturers include Vitalograph (Ireland) , Ltd., Mir Medical Intl. Research Srl and Sensor Medics Corp..

228
Total
228
Cleared
165d
Avg days
1977
Since
228 devices
73–96 of 228
Cleared Apr 30, 1999
SPIROVIT, MODEL SP-250
K984031
Schiller AG
Anesthesiology · 169d
Cleared Dec 21, 1998
MIR SPIROBANK SPIROMETER
K983909
Mir Medical Intl. Research Srl
Anesthesiology · 48d
Cleared Dec 01, 1998
CAIRD TECHNOLOGY SPIROMETER
K971336
Caird Technology
Anesthesiology · 600d
Cleared Nov 24, 1998
FLOWMATE II PLUS, MODEL #4000
K982956
Spirometrics Medical Equipment Co.
Anesthesiology · 92d
Cleared Oct 28, 1998
SPIROCARD
K973138
Qrs Diagnostic, LLC
Anesthesiology · 433d
Cleared Aug 14, 1998
ASTHMA MONITOR AM2
K980876
Erich Jaeger GmbH & Co. KG
Anesthesiology · 161d
Cleared Jul 22, 1998
SPIROBANK PORTABLE PC BASED SPIROMETER
K973456
Futuremed America, Inc.
Anesthesiology · 314d
Cleared Apr 30, 1998
SPIROMETER MODEL NPB-500
K980441
Nellcor Puritan Bennett, Inc.
Anesthesiology · 85d
Cleared Jun 17, 1997
MICRODL DIARYCARD SPIROMETER
K965042
Micro Direct, Inc.
Anesthesiology · 182d
Cleared Feb 14, 1997
GRASEBY ANDERSEN'S, INTEGRITY S700
K963131
Graseby Andersen
Anesthesiology · 186d
Cleared Nov 01, 1996
MICRO SPIROMETER
K963035
Micro Direct, Inc.
Anesthesiology · 88d
Cleared Sep 20, 1996
ASTHMA MONITOR
K960078
Erich Jaeger, Inc.
Anesthesiology · 259d
Cleared Jun 25, 1996
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
K953948
Futuremed America, Inc.
Anesthesiology · 314d
Cleared Apr 12, 1996
FLOWMATE LTE
K954759
Spirometrics Medical Equipment Co.
Anesthesiology · 178d
Cleared Dec 13, 1994
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Feb 10, 1994
L.A.P. II SPRIOMETRY SYSTEM
K932936
Allied Healthcare Products, Inc.
Anesthesiology · 239d
Cleared Oct 21, 1993
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988
Sensor Medics Corp.
Anesthesiology · 437d
Cleared Aug 12, 1993
ESCORT SPIROMETER
K925085
Vitalograph , Ltd.
Anesthesiology · 309d
Cleared Aug 09, 1993
SENSORMEDICS MODEL 6200 AUTOBOX DL
K923989
Sensor Medics Corp.
Anesthesiology · 363d
Cleared Jan 15, 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428
Fukuda Denshi USA, Inc.
Anesthesiology · 238d
Cleared Oct 26, 1992
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111
Sensor Medics Corp.
Anesthesiology · 290d
Cleared Apr 08, 1992
SENSORMEDICS MODEL 922 SPIROMETER
K920246
Sensor Medics Corp.
Anesthesiology · 78d
Cleared Feb 26, 1992
AIRWAY THERMISTOR
K914219
Synectics-Dantec
Anesthesiology · 160d
Cleared Oct 15, 1991
VITALOGRAPH SPIROTRAC III
K912412
Vitalograph , Ltd.
Anesthesiology · 137d