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 |
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 |
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 |
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 |
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 |