BZG · Class II · 21 CFR 868.1840

FDA Product Code BZG: Spirometer, Diagnostic

Leading manufacturers include Mir Medical Intl. Research Srl, Vitalograph (Ireland) , Ltd. and Sdi Diagnostics, Inc..

228
Total
228
Cleared
165d
Avg days
1977
Since
228 devices
73–96 of 228
Cleared Sep 08, 2005
WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
K052158
Welch Allyn, Inc.
Anesthesiology · 30d
Cleared Sep 01, 2005
MODEL 2800 PFT FILTER
K051712
Air Safety, Ltd.
Anesthesiology · 66d
Cleared Aug 29, 2005
POLYTECH PULMONARY FUNCTION FILTER
K042758
Polytechnic Resources, Inc.
Anesthesiology · 329d
Cleared Jul 19, 2005
SPIROTEL
K043528
Mir Medical Intl. Research Srl
Anesthesiology · 210d
Cleared Jun 23, 2005
ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50
K050424
Fim Medical
Anesthesiology · 125d
Cleared May 04, 2005
SPIRO'AIR
K042595
Morgan Scientific, Inc.
Anesthesiology · 223d
Cleared Mar 23, 2005
ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN
K042058
Clement Clarke Intl., Ltd.
Anesthesiology · 236d
Cleared Mar 10, 2004
LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103
K033518
Custom Plastic Products
Anesthesiology · 124d
Cleared Jan 30, 2004
FLOSENSE II, MODEL 29-8040
K033939
Sdi Diagnostics, Inc.
Anesthesiology · 46d
Cleared Dec 09, 2003
SPIROTEL, MODEL 29-1020
K031643
Sdi Diagnostics, Inc.
Anesthesiology · 196d
Cleared Dec 01, 2003
MICROLAB SPIROMETER
K031102
Micro Direct, Inc.
Anesthesiology · 238d
Cleared May 14, 2003
GEM
K030917
Collins Medical, Inc.
Anesthesiology · 51d
Cleared Mar 21, 2003
IQTEQ SPIROMETER
K020102
Iqteq Development
Anesthesiology · 434d
Cleared Mar 14, 2003
GEM, MODEL 004110
K030464
Collins Medical, Inc.
Anesthesiology · 30d
Cleared Dec 18, 2002
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225
Puritan Bennett Corp.
Anesthesiology · 82d
Cleared Oct 18, 2002
COMPAS
K021200
Morgan Scientific, Inc.
Anesthesiology · 185d
Cleared Oct 04, 2002
KOKOMATE
K022276
Ferraris Respiratory, Inc.
Anesthesiology · 81d
Cleared Sep 27, 2002
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103
Puritan Bennett Corp.
Anesthesiology · 91d
Cleared Sep 24, 2002
PULMOLAB EX671 EXERCISE TESTING SYSTEM
K020280
Morgan Medical , Ltd.
Anesthesiology · 239d
Cleared Jul 24, 2002
CLINDATALINK VERSION 1.0 FOR SPIROMETRY
K020004
Compleware Corp.
Anesthesiology · 203d
Cleared Mar 14, 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123
Engineered Medical Systems
Anesthesiology · 176d
Cleared Mar 05, 2002
SPL-50 SPIROLYSER
K010761
Fim Medical
Anesthesiology · 357d
Cleared Feb 11, 2002
SPIROLAB II, MODEL 29
K013812
Sdi Diagnostics, Inc.
Anesthesiology · 88d
Cleared Jan 30, 2002
COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
K013752
Morgan Scientific, Inc.
Anesthesiology · 78d