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 Puritan Bennett Corp..

228
Total
228
Cleared
165d
Avg days
1977
Since
228 devices
49–72 of 228
Cleared Jun 04, 2008
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)
K073155
Vitalograph (Ireland) , Ltd.
Anesthesiology · 209d
Cleared Apr 24, 2008
MEDDORNA WIRELESS PRN SPIROMETER 100
K072722
Meddorna, LLC
Anesthesiology · 211d
Cleared Dec 26, 2007
SPIROBANK G
K072979
Mir Medical Intl. Research Srl
Anesthesiology · 65d
Cleared Jan 31, 2007
ASTRA 300
K061571
Sdi Diagnostics, Inc.
Anesthesiology · 239d
Cleared Jan 26, 2007
ASTRAGUARD PULMONARY FUNCTION FILTER
K062913
Sdi Diagnostics, Inc.
Anesthesiology · 121d
Cleared Dec 14, 2006
PULMOLIFE
K061283
Micro Medical, Ltd.
Anesthesiology · 220d
Cleared Dec 11, 2006
MINISPIR
K061875
Mir Medical Intl. Research Srl
Anesthesiology · 161d
Cleared Dec 01, 2006
SPIROBANK II
K061712
Mir Medical Intl. Research Srl
Anesthesiology · 165d
Cleared Mar 16, 2006
SPIROLAB, SPIROLAB II
K052140
Mir Medical Intl. Research Srl
Anesthesiology · 220d
Cleared Jan 12, 2006
FLOWHANDY ZAN100 USB
K052176
Zan Messgerate GmbH
Anesthesiology · 155d
Cleared Nov 17, 2005
KOKO LEGEND
K051572
Pulmonary Data Services, Inc.
Anesthesiology · 156d
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 Dec 18, 2002
PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE
K023225
Puritan Bennett Corp.
Anesthesiology · 82d
Cleared Sep 27, 2002
PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM
K022103
Puritan Bennett Corp.
Anesthesiology · 91d
Cleared Mar 14, 2002
EMS PULMONARY FUNCTION TESTING FILTER
K013123
Engineered Medical Systems
Anesthesiology · 176d
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