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
49–72 of 228
Cleared Oct 16, 2010
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120
K100687
Vitalograph (Ireland) , Ltd.
Anesthesiology · 220d
Cleared Jul 16, 2010
ASTRASONIC SPIROMETER, MODEL 29-8000
K092813
Sdi Diagnostics, Inc.
Anesthesiology · 305d
Cleared Feb 26, 2010
SPIROPALM
K093174
Cosmed Srl
Anesthesiology · 141d
Cleared Jan 13, 2010
ASTHMA MONITOR AM3
K092890
Carefusion Germany 234 GmbH
Anesthesiology · 114d
Cleared Jul 23, 2009
CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105
K090646
Chest M.I., Inc.
Anesthesiology · 134d
Cleared Jun 25, 2009
CHARTIS CONSOLE
K083199
Pulmonx, Inc.
Anesthesiology · 238d
Cleared Jun 02, 2009
EASY ON-PC SPIROMETER
K090034
Ndd Medizitechnik AG
Anesthesiology · 147d
Cleared May 06, 2009
ASTHMA MONITOR MODEL, AM1
K090486
Cardinal Health Germany 234 GmbH
Anesthesiology · 70d
Cleared Mar 09, 2009
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K082478
Welch Allyn, Inc.
Anesthesiology · 193d
Cleared Mar 02, 2009
THE PFT FILTER
K083233
Pulmonary Filtration Technologies, LLC
Anesthesiology · 119d
Cleared Feb 23, 2009
INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
K083879
Innovision A/S
Anesthesiology · 56d
Cleared Jan 21, 2009
SPIRO-MASTER PC-10 SPIROMETRY SYSTEM
K080921
Chest M.I., Inc.
Anesthesiology · 295d
Cleared Dec 17, 2008
MODIFICATION TO MINISPIR, SPIROLAB III
K082766
Mir Medical Intl. Research Srl
Anesthesiology · 86d
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