FDA 510(k) Applications for Medical Device Product Code "BZH"
(Meter, Peak Flow, Spirometry)

FDA 510(k) Number Applicant Device Name Decision Date
K961779 AVION MEDICAL PRODUCTS, INC. MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER 06/13/1997
K170281 Beijing M&B Electronic Instruments Co., Ltd. MSA100BT Peak Flow Meter 10/06/2017
K133975 BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD MSA100 PEAK FLOW METER 10/03/2014
K172804 Besmed Health Business Corp. Besmed Peak Flow Meter 01/11/2018
K915060 BIOTRINE CORP. ASTECH HOME PEAK FLOW METER 09/11/1992
K813414 BIOTRINE CORP. PEAK FLOW MONITOR 12/31/1981
K934795 CARD GUARD SCIENTIFIC SURVIVAL, LTD. CARD GUARD 04/14/1995
K050853 CARD GUARD SCIENTIFIC SURVIVAL, LTD. PMP4 SPIROPRO 05/04/2005
K954277 CENTER LABORATORIES, INC. ASTECH PEAK FLOW METER 02/21/1996
K982334 CLEMENT CLARKE INTL., LTD. AIRZONE PEAK FLOWMETER 01/14/1999
K980960 CLEMENT CLARKE INTL., LTD. IN-CHECK INSPIRATORY FLOWMETER 06/10/1998
K053156 CLEMENT CLARKE INTL., LTD. MINI-WRIGHT DIGITAL, MODEL 3120001 01/31/2006
K962074 CLEMENT CLARKE INTL., LTD. VM PLUS PEAK FLOWMETER 01/02/1997
K952713 CLEMENT CLARKE, INC. MINI WRIGHT LR AFS 03/29/1996
K914126 CLEMENT CLARKE, INC. VMX MINI-LOG FLOWMETER 03/05/1993
K936110 DURA PHARMACEUTICALS, INC. ASPIRE 03/23/1995
K082899 DYNAMITECH MEDICAL, INC DYNAMIPEAK PEAK FLOW METER 03/10/2009
K982676 ENACT HEALTH MANAGEMENT SYSTEMS AIRWATCH II ZONE 10/29/1998
K982675 ENACT HEALTH MANAGEMENT SYSTEMS AIRWATCH II ZONELESS 10/29/1998
K941226 ENACT HEALTH MANAGEMENT SYSTEMS AIRWATCH MONITOR 11/16/1994
K924343 FERRARIS MEDICAL, INC. WRIGHT POCKET PEAK FLOW METER 06/16/1993
K022124 GALEMED CORP. GALEMED PEAK FLOW METER, MODELS 3751/3752 04/03/2003
K992618 HARWILL MEDICAL (PTY) LTD. RESPALERT 10/29/1999
K980550 HARWILL MEDICAL (PTY) LTD. WHISTLE WATCH 08/27/1998
K896953 HEALTH PRODUCTS, INC. MODIFIED ASSESS(R) PEAK FLOW METER 01/30/1990
K902292 HEALTH PRODUCTS, INC. MODIFIED ASSESS(R) PEAK FLOW METER 08/10/1990
K912866 HEALTH PRODUCTS, INC. PEAK EXPIRATORY FLOW METER 08/13/1992
K934502 HEALTHDYNE, INC. FLOW SPIROMETER 04/04/1994
K962929 HEALTHSCAN PRODUCTS, INC. PERSONAL BEST II 10/24/1996
K962924 HEALTHSCAN PRODUCTS, INC. PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM 10/25/1996
K933889 HEALTHSCAN PRODUCTS, INC. PERSONAL BEST LOW RANGE 09/09/1993
K952909 HEALTHSCAN, INC. AUTOZONE 03/29/1996
K924322 INTERNATIONAL ELECTRONIC TECHNOLOGY CORP. FLOW=MED 04/26/1994
K970507 INTL. MEDICAL, INC. PEAK FLOW METER 06/13/1997
K092335 K-JUMP HEALTH CO., LTD. PEAK EXPIRATORY FLOW METER, KN-9710 04/09/2010
K982995 KORR MEDICAL TECHNOLOGIES, INC. ACCUTRAX, MODEL EPF840 12/04/1998
K940835 MEDTRAC TECHNOLOGIES CORP. PEAKLOG AND DISPLAY SOFTWARE 11/01/1994
K030586 MICRO DIRECT, INC. MICROPEAK 08/27/2003
K031024 MICROLIFE CORP. MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 11/14/2003
K040723 MICROLIFE INTELLECTUAL PROPERTY GMBH MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) 06/10/2004
K181666 MIR Medical International Research Smart One 08/01/2018
K964130 MONAGHAN MEDICAL CORP. AEROGEAR ASTHMA ACTION KIT 01/10/1997
K031514 MONAGHAN MEDICAL CORP. MODIFICATION TO TRUPEAK PEAK FLOW METER 05/23/2003
K991212 MONAGHAN MEDICAL CORP. MODIFICATION TO TRUZONE PEAK FLOW METER 07/01/1999
K926307 MONAGHAN MEDICAL CORP. PEAK FLOW METER 07/22/1993
K123945 MONAGHAN MEDICAL CORP. STRIVE DUAL ZONE PEAK FLOW METER 04/17/2013
K023097 MONAGHAN MEDICAL CORP. TRUEZONE PEAK FLOW METER 03/07/2003
K955234 MONAGHAN MEDICAL CORP. TRUPEAK PEAK FLOW METER 03/18/1996
K963095 MONAGHAN MEDICAL CORP. TRUPEAK PEAK FLOW METER 11/04/1996
K955262 MONAGHAN MEDICAL CORP. TRUZONE PEAK FLOW METER 03/07/1996
K963089 MONAGHAN MEDICAL CORP. TRUZONE PEAK FLOW METER 11/06/1996
K920390 MULTISPIRO, INC. THE PEAK 09/11/1992
K101380 NOBLE MARKETING RXPEAKFLOW 09/13/2010
K010009 PDS HEALTHCARE PRODUCTS, INC. KOKO PEAK KP; KOKO PEAK KP+ 06/01/2001
K013489 PDS HEALTHCARE PRODUCTS, INC. KP + LFM 11/29/2001
K781224 PROJECTS IN HEALTH METER, FLOW, PEAK 10/15/1978
K770580 PROJECTS IN HEALTH PEAK FLOW METER 08/04/1977
K953458 RAIINBOW STEP UP SYSTEMS, INC. RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN 11/17/1995
K853922 RIKO MEDICAL & SCIENTIFIC INSTRUMENT CORP. PLOTTER FOR AS-500 11/14/1985
K953411 ROXON - UNIVERSAL MEDICAL LTD. BREATH-TAKER BREATH-ALERT 06/13/1996
K851265 SOLCOOR, INC. PEAK FLOWMETERS FOR SPIROMETRY 10/29/1985
K152276 Sparo Inc. Wing Smart FEVI and Peak Flow Meter 06/03/2016
K915059 SPIROMETRICS, INC. PEAK FLOW MONITOR 07/27/1992
K980951 STI MEDICAL ONEFLOW 02/25/2000
K940836 TAMARAC SYSTEMS CORP. PEAKLOG AND DISPLAY SOFTWARE 11/01/1994
K980443 THE D&T, INC. PEAK FLOW METER MINIMAX 04/30/1998
K091412 VIASYS HEALTHCARE GMBH CLEAN PEAK FLOW METER 08/21/2009
K781922 VITALOGRAPH LTD. PULMONARY MONITOR 02/13/1979
K943678 VITALOGRAPH, INC. ELECTRONIC FLOW METER 12/14/1995
K991412 VITALOGRAPH, INC. VITALOGRAPH MICRO 02/04/2000


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