BZG · Class II · 21 CFR 868.1840

FDA Product Code BZG: Spirometer, Diagnostic

Leading manufacturers include Puritan Bennett Corp., Fukuda Denshi USA, Inc. and Welch Allyn, Inc..

228
Total
228
Cleared
165d
Avg days
1977
Since
228 devices
25–48 of 228
Cleared Apr 30, 1998
SPIROMETER MODEL NPB-500
K980441
Nellcor Puritan Bennett, Inc.
Anesthesiology · 85d
Cleared Dec 13, 1994
PURITAN-BENNETT RENAISSANCE SPIROMETRY SYSTEMWITH THE OPTIONALRENAISSANCE DB DATA MANAGEMENTSOFTWARE
K944762
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared Jan 15, 1993
FUKUDA DENSHI MODEL SPIROSIFT SP-5000
K922428
Fukuda Denshi USA, Inc.
Anesthesiology · 238d
Cleared May 22, 1991
SPIROSIFT 500A
K904200
Fukuda Denshi USA, Inc.
Anesthesiology · 252d
Cleared Apr 10, 1990
FUKUDA DENSHI MODEL SPIROSIFT 3000
K900391
Fukuda Denshi USA, Inc.
Anesthesiology · 74d
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 Oct 06, 1986
SALTER VOLUCHEK 6600
K863656
Salter Labs
Anesthesiology · 18d
Cleared Jan 14, 1986
MODEL 2120 SPIROSCREEN
K854403
Gould, Inc.
Anesthesiology · 75d
Cleared Jul 30, 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092
Puritan Bennett Corp.
Anesthesiology · 77d
Cleared May 10, 1985
SPIROMED 2
K851620
Draeger Medical, Inc.
Anesthesiology · 22d
Cleared Feb 17, 1984
RESPIRODYNE PULMONARY FUNCTION TEST
K834475
Chesebrough-Pond'S U.S.A. Co.
Anesthesiology · 59d
Cleared May 01, 1981
BREATH METER
K810437
Fred Sammons, Inc.
Anesthesiology · 71d
Cleared Aug 10, 1979
DISPIRO
K791177
Utah Medical Products, Inc.
Anesthesiology · 46d