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 Sdi Diagnostics, Inc..

228
Total
228
Cleared
165d
Avg days
1977
Since
228 devices
97–120 of 228
Cleared Oct 12, 2001
SDI SB OFFICE, MODEL 29-
K011470
Sdi Diagnostics, Inc.
Anesthesiology · 151d
Cleared Jan 18, 2001
PC FLOW +
K001528
Spirometrics Medical Equipment Co.
Anesthesiology · 246d
Cleared Nov 29, 2000
SENSAIRE DIAGNOSTIC SPIROMETER
K001278
Qrs Diagnostic, LLC
Anesthesiology · 222d
Cleared Nov 08, 2000
BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE
K002499
Brentwood Medical Technology Corp.
Anesthesiology · 86d
Cleared Sep 08, 2000
VITALOGRAPH BASE STATION
K000599
Vitalograph, Inc.
Anesthesiology · 199d
Cleared May 23, 2000
NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
K993921
Ndd Medical Technologies
Anesthesiology · 187d
Cleared May 12, 2000
SPIROVIT SP-2, PNEUMOCHECK II
K992823
Schiller AG
Anesthesiology · 263d
Cleared Sep 13, 1999
COLLINS CPL
K992743
Collins Medical, Inc.
Anesthesiology · 28d
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 20, 1995
HM-SPIRO
K951718
Hill-Med, Inc.
Anesthesiology · 251d
Cleared Dec 14, 1995
MASTERSCREEN IOS
K954140
Erich Jaeger GmbH & Co. KG
Anesthesiology · 104d