BZQ · Class II · 21 CFR 868.2375

FDA Product Code BZQ: Monitor, Breathing Frequency

Leading manufacturers include Aequitron Medical, Inc., Healthdyne, Inc. and Edentec Corp..

176
Total
176
Cleared
157d
Avg days
1976
Since
176 devices
49–72 of 176
Cleared Jun 30, 1994
MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
K924875
Synectics-Dantec
Anesthesiology · 654d
Cleared Jan 06, 1994
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
K930790
Bio-Logic Systems Corp.
Anesthesiology · 324d
Cleared Jan 05, 1994
MODEL MEDILOG RAPIDE
K923737
Oxford Medilog, Inc.
Anesthesiology · 527d
Cleared Oct 22, 1993
EDENTEC MODEL 3710 I DIGITAL PRINTER
K921819
Edentec Corp.
Anesthesiology · 555d
Cleared Jan 28, 1993
MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES
K925364
Merit Medical Systems, Inc.
Anesthesiology · 98d
Cleared Jul 02, 1992
EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170
K913749
Edentec Corp.
Anesthesiology · 316d
Cleared Aug 16, 1991
MEDICAL SAFETY CABLE AND LEAD SYSTEM
K912415
Medtronic Vascular
Anesthesiology · 77d
Cleared Jun 20, 1991
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575
Edentec Corp.
Anesthesiology · 190d
Cleared Apr 26, 1991
MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION
K905520
Synectics-Dantec
Anesthesiology · 140d
Cleared Apr 10, 1991
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
K903020
Aequitron Medical, Inc.
Anesthesiology · 273d
Cleared Aug 17, 1990
MODEL 900S APNEA/HEART MONITOR
K903287
Healthdyne, Inc.
Anesthesiology · 37d
Cleared Jul 24, 1990
R-BAND(TM) RESPIRATORY SENSOR
K900264
Buckman Co., Inc.
Anesthesiology · 187d
Cleared Jul 17, 1990
TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)
K884120
S & W Medico Teknik
Anesthesiology · 655d
Cleared Jul 13, 1990
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K901656
Aequitron Medical, Inc.
Anesthesiology · 94d
Cleared Jul 13, 1990
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785
Aequitron Medical, Inc.
Anesthesiology · 17d
Cleared Oct 24, 1989
AR-800PA RESPIRATION MODULE
K891486
Nihon Kohden America, Inc.
Anesthesiology · 221d
Cleared Jan 30, 1989
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K884637
Aequitron Medical, Inc.
Anesthesiology · 84d
Cleared Jun 10, 1988
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K881266
Aequitron Medical, Inc.
Anesthesiology · 78d
Cleared Feb 11, 1988
HEALTHDYNE RATE METER
K874814
Healthdyne, Inc.
Anesthesiology · 79d
Cleared Nov 23, 1987
MODEL 500E INFANT MONITORING SYSTEM
K873791
Ge Medical Systems Information Technologies
Anesthesiology · 67d
Cleared Oct 09, 1987
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR
K872954
Aequitron Medical, Inc.
Anesthesiology · 72d
Cleared Jun 05, 1987
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
K871551
Aequitron Medical, Inc.
Anesthesiology · 44d
Cleared Apr 20, 1987
MODEL 2000W OPTION H CONFIGURATION
K871302
Edentec Corp.
Anesthesiology · 19d
Cleared Mar 09, 1987
LIFEWATCH PLUS
K870661
The Perkin-Elmer Corp.
Anesthesiology · 18d