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
217–228 of 228
Cleared Jun 03, 1983
SPIROTECH ST-5500
K823770
Spirotech, Inc.
Anesthesiology · 171d
Cleared Nov 03, 1982
LIFELINE 4800-C DIGITAL SPIROMETER
K822861
Lifeline Controls
Anesthesiology · 37d
Cleared Apr 15, 1982
AUTOSPIROMETER HI-498
K820599
Medical Equipment Designs, Inc.
Anesthesiology · 42d
Cleared Feb 10, 1982
VIT-O-METER
K820032
Health Scan, Inc.
Anesthesiology · 35d
Cleared Jan 22, 1982
CXD 400
K820036
Cdx Corp.
Anesthesiology · 15d
Cleared Sep 25, 1981
SPIROMETER 210/211
K812039
Medix Medical Electronics (U.S.A.), Inc.
Anesthesiology · 66d
Cleared May 01, 1981
BREATH METER
K810437
Fred Sammons, Inc.
Anesthesiology · 71d
Cleared Nov 05, 1979
MINISPIROMETER SP-1
K791422
Renesco International, Inc.
Anesthesiology · 112d
Cleared Aug 10, 1979
DISPIRO
K791177
Utah Medical Products, Inc.
Anesthesiology · 46d
Cleared Dec 14, 1978
AIRFLOMETER
K780894
Glaxo Australia Ply. , Ltd.
Anesthesiology · 202d
Cleared May 26, 1977
PART NO. 66-00311
K770927
Harlake Cyprane
Anesthesiology · 6d
Cleared May 26, 1977
PART NO. 66-00121
K770928
Harlake Cyprane
Anesthesiology · 6d