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 |
| K180487 | Breathe me LTD | Peak.me | 10/26/2018 |
| K050853 | CARD GUARD SCIENTIFIC SURVIVAL, LTD. | PMP4 SPIROPRO | 05/04/2005 |
| K954277 | CENTER LABORATORIES, INC. | ASTECH PEAK FLOW METER | 02/21/1996 |
| K241338 | Chongqing Moffy Innovation Technology Co.,Ltd. | Peak Flow Meter | 12/31/2024 |
| 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 |
| 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 |
| K022124 | GALEMED CORP. | GALEMED PEAK FLOW METER, MODELS 3751/3752 | 04/03/2003 |
| K222810 | GOSTAR Co., Ltd. | TD-7301 Peak Flow meter | 12/19/2023 |
| K191239 | Guangzhou Homesun Medical Technology Co., Ltd | Smart Peak Flow Meter | 12/06/2019 |
| K992618 | HARWILL MEDICAL (PTY) LTD. | RESPALERT | 10/29/1999 |
| K980550 | HARWILL MEDICAL (PTY) LTD. | WHISTLE WATCH | 08/27/1998 |
| K962929 | HEALTHSCAN PRODUCTS, INC. | PERSONAL BEST II | 10/24/1996 |
| K962924 | HEALTHSCAN PRODUCTS, INC. | PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM | 10/25/1996 |
| K952909 | HEALTHSCAN, INC. | AUTOZONE | 03/29/1996 |
| 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 |
| K232588 | Knox Medical Diagnostics | Aluna 2 | 11/25/2024 |
| K193311 | Knox Medical Diagnostics, Inc. | Aluna | 03/25/2020 |
| K982995 | KORR MEDICAL TECHNOLOGIES, INC. | ACCUTRAX, MODEL EPF840 | 12/04/1998 |
| 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 |
| 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 |
| 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 |
| K953411 | ROXON - UNIVERSAL MEDICAL LTD. | BREATH-TAKER BREATH-ALERT | 06/13/1996 |
| K200832 | Safey Medical Devices Pvt Ltd | Safey Peak Flow Meter | 07/30/2020 |
| K203196 | Shanghai Sonmol Medical Equipment Co., Ltd. | Peak flow meter | 05/26/2021 |
| K152276 | Sparo Inc. | Wing Smart FEVI and Peak Flow Meter | 06/03/2016 |
| K980951 | STI MEDICAL | ONEFLOW | 02/25/2000 |
| K230423 | Taian Dalu Medical Instrument Co., Ltd. | Electronic Peak Flow Meter | 02/23/2024 |
| K980443 | THE D&T, INC. | PEAK FLOW METER MINIMAX | 04/30/1998 |
| K091412 | VIASYS HEALTHCARE GMBH | CLEAN PEAK FLOW METER | 08/21/2009 |
| K991412 | VITALOGRAPH, INC. | VITALOGRAPH MICRO | 02/04/2000 |
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