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 Sdi Diagnostics, Inc..

228
Total
228
Cleared
165d
Avg days
1977
Since
228 devices
193–216 of 228
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 Apr 19, 1985
MICROSPIRO-SDS
K851277
Medical Equipment Designs, Inc.
Anesthesiology · 18d
Cleared Dec 27, 1984
ERGO-OXYSCREEN
K843841
Erich Jaeger, Inc.
Anesthesiology · 87d
Cleared Nov 20, 1984
TURBOAIRE CHALLANGER ENVIRONMENTAL AIR CONTROLLER
K843996
Equilibrated Bio Systems, Inc.
Anesthesiology · 40d
Cleared Nov 20, 1984
B-1000
K844226
Biotrine Corp.
Anesthesiology · 19d
Cleared Nov 20, 1984
SPIROMETRICS 2451 & SMI I
K844333
Spirometrics, Inc.
Anesthesiology · 13d
Cleared Oct 24, 1984
PM-80 PULMOTESTER
K843984
Future Impex Corp.
Anesthesiology · 13d
Cleared Aug 17, 1984
CDX80
K842536
Cdx Corp.
Anesthesiology · 50d
Cleared Jun 26, 1984
SPIROTECH ST-550
K840972
Spirotech, Inc.
Anesthesiology · 112d
Cleared Jun 26, 1984
SPIROMATE AS-500
K842372
Riko Medical & Scientific Instrument Corp.
Anesthesiology · 11d
Cleared Jun 15, 1984
PULMONARY FUNCTION SYSTEM
K842041
Sensor Medics Corp.
Anesthesiology · 25d
Cleared May 14, 1984
CHESTAC-25F SPIROMETER
K840908
Medical Equipment Designs, Inc.
Anesthesiology · 75d
Cleared May 14, 1984
FRC 85 SERIES SPIROMETER
K840929
Medical Equipment Designs, Inc.
Anesthesiology · 73d
Cleared Apr 30, 1984
PULMOMETER
K831803
Kinetics Measurement Corp.
Anesthesiology · 332d
Cleared Apr 30, 1984
RESPIROMETER
K832401
Kinetix
Anesthesiology · 285d
Cleared Mar 05, 1984
PULMONARY FUNCTION TESTING STS
K840741
Circadian, Inc.
Anesthesiology · 33d
Cleared Feb 17, 1984
RESPIRODYNE PULMONARY FUNCTION TEST
K834475
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 59d
Cleared Sep 29, 1983
FUKUNDA SANGYO UNITS ELECTRONIC SPIRO
K832430
Future Impex Corp.
Anesthesiology · 69d
Cleared Sep 29, 1983
FUKUNDA SANGYA UNITS PULMOTESTER PM60
K832431
Future Impex Corp.
Anesthesiology · 69d
Cleared Sep 29, 1983
SPIRO ANALYZER ST-100 AUTOMATIC SPIRO
K832432
Future Impex Corp.
Anesthesiology · 69d
Cleared Sep 29, 1983
AUTOMATIC SPIROMETER ST-200
K832433
Future Impex Corp.
Anesthesiology · 69d
Cleared Aug 12, 1983
OHIO MODEL 922 SPIROMETER
K832185
Airco/Ohio Medical Products
Anesthesiology · 37d
Cleared Jun 24, 1983
SPIROMETRICS BREON 2400 & SMI 2400
K831497
Spirometrics, Inc.
Anesthesiology · 45d