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
145–168 of 228
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 Nov 19, 1991
HMS-5000
K914085
Vitalog Monitoring,Inc.
Anesthesiology · 74d
Cleared Oct 15, 1991
VITALOGRAPH SPIROTRAC III
K912412
Vitalograph , Ltd.
Anesthesiology · 137d
Cleared Aug 20, 1991
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K904625
Synectics-Dantec
Anesthesiology · 314d
Cleared Aug 02, 1991
HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED
K910950
Vitalog Monitoring,Inc.
Anesthesiology · 157d
Cleared Jul 22, 1991
SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION
K912234
Somnitec, Inc.
Anesthesiology · 66d
Cleared May 22, 1991
SPIROSIFT 500A
K904200
Fukuda Denshi USA, Inc.
Anesthesiology · 252d
Cleared Apr 16, 1991
RESPI-PAK RT-PAK
K910452
Cns, Inc.
Anesthesiology · 74d
Cleared Feb 25, 1991
SOMNIGAUGE THORACIC/ABDOMINAL EXPANSION MON. SYST.
K904117
Dawn Medical
Anesthesiology · 172d
Cleared Feb 25, 1991
SOMNIPROBE II NASAL AND BUCCAL AIRFLOW MON. SYST.
K904118
Dawn Medical
Anesthesiology · 172d
Cleared Jan 30, 1991
PM2002 CC, ARISTOCRAT AND ARISTOCRAT DELUXE
K904947
Planmeca USA, Inc.
Anesthesiology · 90d
Cleared Sep 04, 1990
TUBA TM (TRANSIT-TIME ULTRASONIC BREATH ANALYZER)
K900331
Ghg Medizin-Elektronik AG
Anesthesiology · 224d
Cleared Jul 23, 1990
SPIRO ANALYZER MODEL ST 250
K901308
Futuremed Div. of Future Impex Corp.
Anesthesiology · 125d
Cleared Apr 10, 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391
Fukuda Denshi USA, Inc.
Anesthesiology · 74d
Cleared Apr 03, 1990
LDW SPIROMETRY SYSTEM
K896300
Lanpher Diagnostic Workstations, Inc.
Anesthesiology · 155d
Cleared Apr 03, 1990
SERIAL FLOW
K900673
Spirometrics, Inc.
Anesthesiology · 49d
Cleared Apr 03, 1990
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
K901057
Spirometrics, Inc.
Anesthesiology · 28d
Cleared Mar 01, 1990
SPIROSCAN 4000
K896924
Brentwood Instruments, Inc.
Anesthesiology · 79d
Cleared Feb 12, 1990
MULTIMED (TM) PULMONARY FUNCTION TESTING SYSTEM
K895414
Integrated Medical Systems, Inc.
Anesthesiology · 164d
Cleared Feb 02, 1990
WRIGHT VENTILOMETER VM-1
K895953
Clement Clarke, Inc.
Anesthesiology · 114d
Cleared Jan 12, 1990
MODIFIED SPIROSCAN 1000
K897094
Fukuda Denshi USA, Inc.
Anesthesiology · 23d
Cleared Jan 09, 1990
SPIROTEQ
K894556
System Analysis Corp.
Anesthesiology · 173d
Cleared Jan 09, 1990
SCHILLER MODEL SP-100 SPIROVIT(TM)
K896120
Schiller America, Inc.
Anesthesiology · 77d