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
121–144 of 228
Cleared Nov 17, 1995
DISCOVERY GRAPHIC PORTABLE SPIROMETER
K950223
Futuremed America, Inc.
Anesthesiology · 311d
Cleared Aug 11, 1995
DX1
K951227
Creative Biomedics, Inc.
Anesthesiology · 144d
Cleared Aug 04, 1995
VITALOGRAPH MODEL 2120
K946075
Vitalograph, Inc.
Anesthesiology · 242d
Cleared Jul 07, 1995
POLYGRAM SOFTWARE
K946322
Synectics Medical, Inc.
Anesthesiology · 191d
Cleared Apr 14, 1995
PORTA-SCREEN SPIROMETER
K951367
S & M Instrument Co.
Anesthesiology · 18d
Cleared Feb 23, 1995
FUKUDA SANGYO MODEL SPIROANALYZER ST-180
K943546
Spirosoft Northamerica, Inc.
Anesthesiology · 217d
Cleared Dec 13, 1994
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Oct 14, 1994
ADAM SHELL THERMOCOUPLE ASSEMBLY
K944175
Pro-Tech Services, Inc.
Anesthesiology · 49d
Cleared Jul 13, 1994
DISPOSABLE BACTERIOLOGICAL FILTER
K942779
Vitalograph, Inc.
Anesthesiology · 30d
Cleared Feb 10, 1994
L.A.P. II SPRIOMETRY SYSTEM
K932936
Allied Healthcare Products, Inc.
Anesthesiology · 239d
Cleared Feb 04, 1994
GS-MODULAR (GOLD STANDARD - MODULAR)
K925459
Warren E. Collins, Inc.
Anesthesiology · 463d
Cleared Oct 21, 1993
SENSORMEDICS MODEL 2200 PULMONARY FUNCTION LABS
K923988
Sensor Medics Corp.
Anesthesiology · 437d
Cleared Aug 12, 1993
ESCORT SPIROMETER
K925085
Vitalograph , Ltd.
Anesthesiology · 309d
Cleared Aug 09, 1993
SENSORMEDICS MODEL 6200 AUTOBOX DL
K923989
Sensor Medics Corp.
Anesthesiology · 363d
Cleared May 06, 1993
FLOWSCAN
K924413
Electrocaine Medical System
Anesthesiology · 248d
Cleared Jan 27, 1993
SPIROLITE MODEL MSC-201 SPIROMETER
K921513
Medical Systems Corp.
Anesthesiology · 302d
Cleared Jan 15, 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428
Fukuda Denshi USA, Inc.
Anesthesiology · 238d
Cleared Dec 23, 1992
THE KEYSTONE SYSTEM
K920877
S & M Instrument Co.
Anesthesiology · 301d
Cleared Oct 26, 1992
SENSORMEDICS MODEL 2130 SPIEOMETRY SYSTEM
K920111
Sensor Medics Corp.
Anesthesiology · 290d
Cleared Jul 02, 1992
KOKO SPIROMETER
K914272
Ferraris Respiratory, Inc.
Anesthesiology · 282d
Cleared Jul 02, 1992
MULTISPIRO-SX
K915451
Multispiro, Inc.
Anesthesiology · 210d
Cleared May 22, 1992
CANNULA STYLE THERMOCOUPLES
K913396
Pro-Tech, Inc.
Anesthesiology · 297d
Cleared May 20, 1992
EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS
K913395
Pro-Tech, Inc.
Anesthesiology · 295d
Cleared May 01, 1992
PFF-1
K914205
Cybermedic, Inc.
Anesthesiology · 225d