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Panels › Anesthesiology › Product code BZQ · Class 2

Monitor, Breathing Frequency

Regulation 868.2375

2510(k)s in 12 months (176 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
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Top companies in BZQ

Company510(k)sRecalls
Aequitron Medical, Inc.90
Earlysense, Ltd.80
Healthdyne, Inc.80
Edentec Corp.60
Ge Medical Systems Information Technologies60
Braebon Medical Corp.40
Arvee Medical, Inc.30
Epm Information Systems, Inc.30
Gereonics, Inc.30
Honeywell, Inc.30
Decided510(k)Device and applicantCode
Jun 25, 2026K253274BedDot (G1)
Intelligent Dots, LLC
BZQ
Jun 11, 2026K251326Respiration Rate algorithm
Edwards Lifesciences, LLC
BZQ
Sep 26, 2025K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Linshom Medical, Inc.
BZQ
Aug 5, 2025K250934Respiree Cardio- Respiratory Monitor System
Respiree Pte, Ltd., SG
BZQ
Jun 27, 2025K243183RTMsense Respiratory Monitoring System
Rtm Vital Signs, LLC
BZQ
Apr 9, 2025K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)
Faceheart Corp., KY
BZQ
Apr 4, 2025K242001Philips VSC-MEDlib
Philips Medical Systems Nederland B.V., NL
BZQ
Mar 28, 2025K233953Makani Science™ Respiration Monitoring System
Makani Science, Inc.
BZQ
Feb 28, 2025K242798Airmod
Heroic Faith International , Ltd., TW
BZQ
Sep 11, 2024K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
Linshom Medical, Inc.
BZQ
Mar 8, 2023K223681Respiree Cardio-Respiratory Monitor
Respiree Pte, Ltd., SG
BZQ
Dec 15, 2022K221555Dozee VS
Turtle Shell Technologies Private Limited, IN
BZQ
Nov 18, 2022K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense
Baxter Healthcare Corproration
BZQ
Oct 7, 2022K220111RespiraSense
Pmd Solutions, IE
BZQ
Nov 23, 2021K211387Breathe Easy Mobile Respiratory Monitor (MRM)
Sound Life Sciences, Inc.
BZQ
Mar 4, 2021K202018Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring Sys
Hill-Rom, Inc.
BZQ
Jun 24, 2020K200445The C100 Contactless Breathing Monitor
Circadia Technologies, Ltd., GB
BZQ
Jan 30, 2020K190734Linshom Respiratory Monitoring Device (LRMD)
Linshom Management, LLC
BZQ
Dec 19, 2019K190775The RHEA Vital Sign Vigilance System
Shenzhen Fiber Medical Technology Co. , Ltd., CN
BZQ
Sep 5, 2018K173976Masimo Acoustic Respiration Sensors, infant and neonate
Masimo Corporation
BZQ
May 7, 2018K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System p
Hill-Rom, Inc.
BZQ
Jan 4, 2018K171836EarlySense Bed Sensing Unit
Earlysense, Ltd., IL
BZQ
May 6, 2016K152911EarlySense Insight Sytem
Earlysense, Ltd., IL
BZQ
Mar 10, 2016K151940Thora-3Di, Model T-01
Pneumacare Limited, GB
BZQ
Jun 13, 2014K133661CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM
Earlysense, Ltd., IL
BZQ
Mar 26, 2014K132320INTELLIVUE CL RESPIRATION POD
Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, DE
BZQ
Dec 26, 2013K130570NEUROVISION MEDICAL MOTION SENSOR
Neurovision Medical Products, Inc.
BZQ
Dec 18, 2013K131379EARLYSENSE
Earlysense, Ltd., IL
BZQ
Apr 12, 2013K122223NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO
Philips Medizin Systeme Boeblingen GmbH, DE
BZQ
Jun 8, 2012K120465EARLYSENSE (EVERON) SYSTEM
Earlysense, Ltd., IL
BZQ
Mar 15, 2012K111933COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
Covidien
BZQ
Jul 21, 2011K103631SLEEPMINDER BREATHING FREQUENCY INDICATOR
Biancamed Limited, IE
BZQ
Jun 23, 2010K100773KAI SPOT MODEL KMS 200
Kai Medical, Inc.
BZQ
May 24, 2010K092062EVERON 1.0
Earlysense, Ltd., IL
BZQ
Nov 24, 2009K092685PNEUMOTHERML, MODEL: 5800
Salter Labs
BZQ
Jun 5, 2009K090273KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
Kai Sensors, Inc.
BZQ
Mar 25, 2009K082465EVERON
Earlysense, Ltd., IL
BZQ
Jul 25, 2008K080922SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR
Salter Labs, Division of Regulatory Affairs
BZQ
Nov 15, 2007K070375EARLYSENSE ES-16 SYSTEM
Earlysense, Ltd., IL
BZQ
Jun 13, 2007K062883GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR
Gereonics, Inc.
BZQ
Sep 30, 2005K051779ANDROFLOW - RESPIRATORY RATE MONITOR
Andromed, Inc., CA
BZQ
Apr 26, 2004K040605DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 3100
Dymedix, Inc.
BZQ
Feb 5, 2001K003704OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)
Optovent AB
BZQ
Aug 25, 2000K001743ULTIMA SMARTBELT, MODEL 0560
Braebon Medical Corp., CA
BZQ
May 11, 2000K001030RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
Dymedix, Inc.
BZQ
Apr 28, 1999K991411GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
Gereonics, Inc.
BZQ
Feb 8, 1999K983449GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR
Gereonics, Inc.
BZQ
Feb 2, 1999K981725OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 9700
Optovent, Inc.
BZQ
Dec 30, 1998K984431ULTIMA AIRFLOW PRESSURE SENSOR
Braebon Medical Corp., CA
BZQ
Oct 5, 1998K982550BROWSER (EVENT SOFTWARE) MODEL # 4500E
Respironics, Inc.
BZQ

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