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
97–120 of 228
Cleared Aug 20, 1991
SYNECTICS LIBERTY SYSTEM, PC POLYGRAF AND POLYGRAM
K904625
Synectics-Dantec
Anesthesiology · 314d
Cleared May 22, 1991
SPIROSIFT 500A
K904200
Fukuda Denshi USA, Inc.
Anesthesiology · 252d
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 Mar 01, 1990
SPIROSCAN 4000
K896924
Brentwood Instruments, Inc.
Anesthesiology · 79d
Cleared Jan 12, 1990
MODIFIED SPIROSCAN 1000
K897094
Fukuda Denshi USA, Inc.
Anesthesiology · 23d
Cleared Nov 02, 1989
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253
Welch Allyn, Inc.
Anesthesiology · 73d
Cleared Apr 21, 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522
Puritan Bennett Corp.
Anesthesiology · 78d
Cleared Sep 26, 1988
629V SPIROMETER, PULMONARY FUNCTION ANALYZER
K881402
American Electromedics Corp.
Anesthesiology · 175d
Cleared Aug 29, 1988
VITALOGRAPH-ALPHA
K873562
Vitalograph , Ltd.
Anesthesiology · 362d
Cleared Dec 02, 1987
SPIRO ANALYZER ST-300
K873817
Futuremed Div. of Future Impex Corp.
Anesthesiology · 72d
Cleared Oct 06, 1986
SALTER VOLUCHEK 6600
K863656
Salter Labs
Anesthesiology · 18d
Cleared Feb 05, 1986
SCREENMATE
K853409
Erich Jaeger, Inc.
Anesthesiology · 177d
Cleared Jan 14, 1986
MODEL 2120 SPIROSCREEN
K854403
Gould, Inc.
Anesthesiology · 75d
Cleared Dec 24, 1985
VITALOGRAPH COMPACT
K854526
Vitalograph , Ltd.
Anesthesiology · 41d
Cleared Nov 07, 1985
PALL PULMONARY FUNCTION FILTER
K854062
Pall Biomedical Products Co.
Anesthesiology · 34d
Cleared Jul 30, 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Jul 05, 1985
PULMONARY TEST SYSTEM FUDAC-30
K852307
Futuremed Div. of Future Impex Corp.
Anesthesiology · 37d
Cleared Jul 01, 1985
SPIRO SCAN
K851135
Brentwood Instruments, Inc.
Anesthesiology · 102d
Cleared Jul 01, 1985
PNEUMOSCOPE
K852337
Erich Jaeger, Inc.
Anesthesiology · 31d
Cleared Jun 24, 1985
ST-460 SPIRO ANALYZER SPIROMETER
K852308
Futuremed Div. of Future Impex Corp.
Anesthesiology · 26d
Cleared May 10, 1985
SPIROMED 2
K851620
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared Dec 27, 1984
ERGO-OXYSCREEN
K843841
Erich Jaeger, Inc.
Anesthesiology · 87d
Cleared Jun 15, 1984
PULMONARY FUNCTION SYSTEM
K842041
Sensor Medics Corp.
Anesthesiology · 25d