FDA Product Code
FDA Product Code BZH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.1860
510(k) Clearances — 81 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | 2026-06-23 | Traditional | PDF ↗ |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 | Traditional | PDF ↗ |
| K241338 | Peak Flow Meter | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 | Traditional | PDF ↗ |
| K232588 | Aluna 2 | Knox Medical Diagnostics | 2024-11-25 | Traditional | PDF ↗ |
| K230423 | Electronic Peak Flow Meter | Taian Dalu Medical Instrument Co., Ltd. | 2024-02-23 | Traditional | PDF ↗ |
| K222810 | TD-7301 Peak Flow meter | Gostar Co., Ltd. | 2023-12-19 | Traditional | PDF ↗ |
| K203196 | Peak flow meter | Shanghai Sonmol Medical Equipment Co., Ltd. | 2021-05-26 | Traditional | PDF ↗ |
| K200832 | Safey Peak Flow Meter | Safey Medical Devices Pvt, Ltd. | 2020-07-30 | Traditional | PDF ↗ |
| K193311 | Aluna | Knox Medical Diagnostics, Inc. | 2020-03-25 | Traditional | PDF ↗ |
| K191239 | Smart Peak Flow Meter | Guangzhou Homesun Medical Technology Co., Ltd. | 2019-12-06 | Traditional | PDF ↗ |
| K180487 | Peak.me | Breathe Me, Ltd. | 2018-10-26 | Traditional | PDF ↗ |
| K181666 | Smart One | Mir Medical International Research | 2018-08-01 | Traditional | PDF ↗ |
| K172804 | Besmed Peak Flow Meter | Besmed Health Business Corp | 2018-01-11 | Traditional | PDF ↗ |
| K170281 | MSA100BT Peak Flow Meter | Beijing M&B Electronic Instruments Co., Ltd. | 2017-10-06 | Traditional | PDF ↗ |
| K152276 | Wing Smart FEVI and Peak Flow Meter | Sparo, Inc. | 2016-06-03 | Traditional | PDF ↗ |
| K133975 | MSA100 PEAK FLOW METER | Beijing M&B Electronic Instruments Co., Ltd. | 2014-10-03 | Traditional | PDF ↗ |
| K123945 | STRIVE DUAL ZONE PEAK FLOW METER | Monaghan Medical Corp. | 2013-04-17 | Traditional | PDF ↗ |
| K101380 | RXPEAKFLOW | Noble Marketing | 2010-09-13 | Traditional | PDF ↗ |
| K092335 | PEAK EXPIRATORY FLOW METER, KN-9710 | K-Jump Health Co., Ltd. | 2010-04-09 | Traditional | PDF ↗ |
| K091412 | CLEAN PEAK FLOW METER | Viasys Healthcare GmbH | 2009-08-21 | Special | PDF ↗ |
| K082899 | DYNAMIPEAK PEAK FLOW METER | Dynamitech Medical, Inc. | 2009-03-10 | Traditional | PDF ↗ |
| K053156 | MINI-WRIGHT DIGITAL, MODEL 3120001 | Clement Clarke Intl., Ltd. | 2006-01-31 | Traditional | PDF ↗ |
| K050853 | PMP4 SPIROPRO | Card Guard Scientific Survival , Ltd. | 2005-05-04 | Special | PDF ↗ |
| K040723 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE) | Microlife Intellectual Property GmbH | 2004-06-10 | Abbreviated | PDF ↗ |
| K031024 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 | Microlife Corp. | 2003-11-14 | Traditional | PDF ↗ |
| K030586 | MICROPEAK | Micro Direct, Inc. | 2003-08-27 | Traditional | PDF ↗ |
| K031514 | MODIFICATION TO TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 2003-05-23 | Special | PDF ↗ |
| K022124 | GALEMED PEAK FLOW METER, MODELS 3751/3752 | Galemed Corp. | 2003-04-03 | Traditional | PDF ↗ |
| K023097 | TRUEZONE PEAK FLOW METER | Monaghan Medical Corp. | 2003-03-07 | Abbreviated | PDF ↗ |
| K013489 | KP + LFM | Pds Healthcare Products, Inc. | 2001-11-29 | Traditional | PDF ↗ |
| K010009 | KOKO PEAK KP; KOKO PEAK KP+ | Pds Healthcare Products, Inc. | 2001-06-01 | Abbreviated | PDF ↗ |
| K980951 | ONEFLOW | Sti Medical | 2000-02-25 | Traditional | PDF ↗ |
| K991412 | VITALOGRAPH MICRO | Vitalograph, Inc. | 2000-02-04 | Traditional | PDF ↗ |
| K992618 | RESPALERT | Harwill Medical (Pty) , Ltd. | 1999-10-29 | Traditional | PDF ↗ |
| K991212 | MODIFICATION TO TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1999-07-01 | Abbreviated | PDF ↗ |
| K982334 | AIRZONE PEAK FLOWMETER | Clement Clarke Intl., Ltd. | 1999-01-14 | Traditional | PDF ↗ |
| K982995 | ACCUTRAX, MODEL EPF840 | Korr Medical Technologies, Inc. | 1998-12-04 | Traditional | PDF ↗ |
| K982676 | AIRWATCH II ZONE | Enact Health Management Systems | 1998-10-29 | Traditional | PDF ↗ |
| K982675 | AIRWATCH II ZONELESS | Enact Health Management Systems | 1998-10-29 | Traditional | PDF ↗ |
| K980550 | WHISTLE WATCH | Harwill Medical (Pty) , Ltd. | 1998-08-27 | Traditional | PDF ↗ |
| K980960 | IN-CHECK INSPIRATORY FLOWMETER | Clement Clarke Intl., Ltd. | 1998-06-10 | Traditional | PDF ↗ |
| K980443 | PEAK FLOW METER MINIMAX | The D&T, Inc. | 1998-04-30 | Traditional | PDF ↗ |
| K970507 | PEAK FLOW METER | Intl. Medical, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K961779 | MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER | Avion Medical Products, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K964130 | AEROGEAR ASTHMA ACTION KIT | Monaghan Medical Corp. | 1997-01-10 | Traditional | PDF ↗ |
| K962074 | VM PLUS PEAK FLOWMETER | Clement Clarke Intl., Ltd. | 1997-01-02 | Traditional | PDF ↗ |
| K963089 | TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1996-11-06 | Traditional | PDF ↗ |
| K963095 | TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 1996-11-04 | Traditional | PDF ↗ |
| K962924 | PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM | Healthscan Products, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K962929 | PERSONAL BEST II | Healthscan Products, Inc. | 1996-10-24 | Traditional | PDF ↗ |
| K953411 | BREATH-TAKER BREATH-ALERT | Roxon - Universal Medical , Ltd. | 1996-06-13 | Traditional | PDF ↗ |
| K952909 | AUTOZONE | Health Scan, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K952713 | MINI WRIGHT LR AFS | Clement Clarke, Inc. | 1996-03-29 | Traditional | PDF ↗ |
| K955234 | TRUPEAK PEAK FLOW METER | Monaghan Medical Corp. | 1996-03-18 | Traditional | PDF ↗ |
| K955262 | TRUZONE PEAK FLOW METER | Monaghan Medical Corp. | 1996-03-07 | Traditional | PDF ↗ |
| K954277 | ASTECH PEAK FLOW METER | Center Laboratories, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K943678 | ELECTRONIC FLOW METER | Vitalograph, Inc. | 1995-12-14 | Traditional | PDF ↗ |
| K953458 | RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN | Raiinbow Step UP Systems, Inc. | 1995-11-17 | Traditional | PDF ↗ |
| K934795 | CARD GUARD | Card Guard Scientific Survival , Ltd. | 1995-04-14 | Traditional | PDF ↗ |
| K936110 | ASPIRE | Dura Pharmaceuticals, Inc. | 1995-03-23 | Traditional | PDF ↗ |
| K941226 | AIRWATCH MONITOR | Enact Health Management Systems | 1994-11-16 | Traditional | PDF ↗ |
| K940835 | PEAKLOG AND DISPLAY SOFTWARE | Medtrac Technologies Corp. | 1994-11-01 | Traditional | PDF ↗ |
| K940836 | PEAKLOG AND DISPLAY SOFTWARE | Tamarac Systems Corp. | 1994-11-01 | Traditional | PDF ↗ |
| K924322 | FLOW=MED | International Electronic Technology Corp. | 1994-04-26 | Traditional | PDF ↗ |
| K934502 | FLOW SPIROMETER | Healthdyne, Inc. | 1994-04-04 | Traditional | PDF ↗ |
| K933889 | PERSONAL BEST LOW RANGE | Healthscan Products, Inc. | 1993-09-09 | Traditional | PDF ↗ |
| K926307 | PEAK FLOW METER | Monaghan Medical Corp. | 1993-07-22 | Traditional | PDF ↗ |
| K924343 | WRIGHT POCKET PEAK FLOW METER | Ferraris Medical, Inc. | 1993-06-16 | Traditional | PDF ↗ |
| K914126 | VMX MINI-LOG FLOWMETER | Clement Clarke, Inc. | 1993-03-05 | Traditional | PDF ↗ |
| K915060 | ASTECH HOME PEAK FLOW METER | Biotrine Corp. | 1992-09-11 | Traditional | PDF ↗ |
| K920390 | THE PEAK | Multispiro, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K912866 | PEAK EXPIRATORY FLOW METER | Health Products, Inc. | 1992-08-13 | Traditional | PDF ↗ |
| K915059 | PEAK FLOW MONITOR | Spirometrics, Inc. | 1992-07-27 | Traditional | PDF ↗ |
| K902292 | MODIFIED ASSESS(R) PEAK FLOW METER | Health Products, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K896953 | MODIFIED ASSESS(R) PEAK FLOW METER | Health Products, Inc. | 1990-01-30 | Traditional | PDF ↗ |
| K853922 | PLOTTER FOR AS-500 | Riko Medical & Scientific Instrument Corp. | 1985-11-14 | Traditional | PDF ↗ |
| K851265 | PEAK FLOWMETERS FOR SPIROMETRY | Solcoor, Inc. | 1985-10-29 | Traditional | PDF ↗ |
| K813414 | PEAK FLOW MONITOR | Biotrine Corp. | 1981-12-31 | Traditional | PDF ↗ |
| K781922 | PULMONARY MONITOR | Vitalograph , Ltd. | 1979-02-13 | Traditional | PDF ↗ |
| K781224 | METER, FLOW, PEAK | Projects IN Health | 1978-10-15 | Traditional | PDF ↗ |
| K770580 | PEAK FLOW METER | Projects IN Health | 1977-08-04 | Traditional | PDF ↗ |
Product code BZH · Class II · Anesthesiology. Data: openFDA.