FDA 510(k) Applications for Medical Device Product Code "BZQ"
(Monitor, Breathing Frequency)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K961972 | AEQUITRON MEDICAL, INC. | MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR | 04/18/1997 |
| K981728 | ALEXANDER MFG. CO. | ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134 | 06/26/1998 |
| K051779 | ANDROMED, INC. | ANDROFLOW - RESPIRATORY RATE MONITOR | 09/30/2005 |
| K223246 | Baxter Healthcare Corproration | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | 11/18/2022 |
| K103631 | BIANCAMED LIMITED | SLEEPMINDER BREATHING FREQUENCY INDICATOR | 07/21/2011 |
| K984431 | BRAEBON MEDICAL CORP. | ULTIMA AIRFLOW PRESSURE SENSOR | 12/30/1998 |
| K981445 | BRAEBON MEDICAL CORP. | ULTIMA AIRFLOW SENSOR, 0510 | 10/05/1998 |
| K982216 | BRAEBON MEDICAL CORP. | ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522 | 09/11/1998 |
| K001743 | BRAEBON MEDICAL CORP. | ULTIMA SMARTBELT, MODEL 0560 | 08/25/2000 |
| K200445 | Circadia Technologies Ltd. | The C100 Contactless Breathing Monitor | 06/24/2020 |
| K111933 | COVIDIEN | COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 | 03/15/2012 |
| K040605 | DYMEDIX, INC. | DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100 | 04/26/2004 |
| K001030 | DYMEDIX, INC. | RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S | 05/11/2000 |
| K133661 | EARLYSENSE LTD. | CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM | 06/13/2014 |
| K131379 | EARLYSENSE LTD. | EARLYSENSE | 12/18/2013 |
| K120465 | EARLYSENSE LTD. | EARLYSENSE (EVERON) SYSTEM | 06/08/2012 |
| K171836 | EarlySense Ltd. | EarlySense Bed Sensing Unit | 01/04/2018 |
| K070375 | EARLYSENSE LTD. | EARLYSENSE ES-16 SYSTEM | 11/15/2007 |
| K152911 | EarlySense Ltd. | EarlySense Insight Sytem | 05/06/2016 |
| K082465 | EARLYSENSE LTD. | EVERON | 03/25/2009 |
| K092062 | EARLYSENSE LTD. | EVERON 1.0 | 05/24/2010 |
| K953363 | EDENTEC CORP. | OXIFLOW DIGITAL RECORDER | 02/06/1996 |
| K243966 | FaceHeart Corp. | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | 04/09/2025 |
| K962781 | GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES | COROMETRICS MODEL 510 AND 511 MONITOR | 03/06/1997 |
| K983449 | GEREONICS, INC. | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | 02/08/1999 |
| K062883 | GEREONICS, INC. | GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR | 06/13/2007 |
| K991411 | GEREONICS, INC. | GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR | 04/28/1999 |
| K242798 | Heroic Faith International Ltd. | Airmod | 02/28/2025 |
| K180079 | Hill-Rom Inc. | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | 05/07/2018 |
| K202018 | Hill-Rom, Inc. | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | 03/04/2021 |
| K100773 | KAI MEDICAL, INC. | KAI SPOT MODEL KMS 200 | 06/23/2010 |
| K090273 | KAI SENSORS, INC | KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100 | 06/05/2009 |
| K190734 | Linshom Management LLC | Linshom Respiratory Monitoring Device (LRMD) | 01/30/2020 |
| K240271 | Linshom Medical Inc. | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | 09/11/2024 |
| K233953 | Makani Science, Inc. | Makani ScienceÖ Respiration Monitoring System | 03/28/2025 |
| K173976 | Masimo Corporation | Masimo Acoustic Respiration Sensors, infant and neonate | 09/05/2018 |
| K130570 | NEUROVISION MEDICAL PRODUCTS, INC. | NEUROVISION MEDICAL MOTION SENSOR | 12/26/2013 |
| K003704 | OPTOVENT AB | OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE) | 02/05/2001 |
| K981725 | OPTOVENT, INC. | OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700 | 02/02/1999 |
| K242001 | Philips Medical Systems Nederland B.V. | Philips VSC-MEDlib | 04/04/2025 |
| K122223 | PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH | NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO | 04/12/2013 |
| K132320 | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN | INTELLIVUE CL RESPIRATION POD | 03/26/2014 |
| K220111 | PMD Solutions | RespiraSense | 10/07/2022 |
| K151940 | PneumaCare LIMITED | Thora-3Di, Model T-01 | 03/10/2016 |
| K960851 | PRO-TECH SERVICES, INC. | THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR | 09/17/1996 |
| K223681 | Respiree PTE Ltd. | Respiree Cardio-Respiratory Monitor | 03/08/2023 |
| K982550 | RESPIRONICS, INC. | BROWSER (EVENT SOFTWARE) MODEL # 4500E | 10/05/1998 |
| K243183 | RTM Vital Signs, LLC | RTM Sense (A-0001) | 06/27/2025 |
| K092685 | SALTER LABS | PNEUMOTHERML, MODEL: 5800 | 11/24/2009 |
| K080922 | SALTER LABS, DIVISION OF REGULATORY AFFAIRS | SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR | 07/25/2008 |
| K190775 | Shenzhen Fiber Medical Technology Co. Ltd. | The RHEA Vital Sign Vigilance System | 12/19/2019 |
| K211387 | Sound Life Sciences, Inc. | Breathe Easy Mobile Respiratory Monitor (MRM) | 11/23/2021 |
| K221555 | Turtle Shell Technologies Private Limited | Dozee VS | 12/15/2022 |
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