Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- BXHGauge, Gas Pressure, Cylinder/Pipeline1Product Code
- BXMStimulator, Nerve, Ac-Powered2Product Code
- BXNStimulator, Nerve, Battery-Powered2Product Code
- BXOTransducer, Gas Pressure1Product Code
- BXPTransducer, Gas Flow1Product Code
- BXXCalibrator, Pressure, Gas1Product Code
- BXYFlowmeter, Calibration, Gas1Product Code
- BYMTube, Thorpe, Uncompensated1Product Code
- BYRTransducer, Gas Pressure, Differential1Product Code
- BZQMonitor, Breathing Frequency2Product Code
- K250093Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)2Cleared 510(K)
- K250934Respiree Cardio- Respiratory Monitor System2Cleared 510(K)
- K243183RTMsense Respiratory Monitoring System2Cleared 510(K)
- K243966FaceHeart Vitals Software Development Kit (FH vitals SDK-RR)2Cleared 510(K)
- K242001Philips VSC-MEDlib2Cleared 510(K)
- K233953Makani Science™ Respiration Monitoring System2Cleared 510(K)
- K242798Airmod2Cleared 510(K)
- K240271Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)2Cleared 510(K)
- K223681Respiree Cardio-Respiratory Monitor2Cleared 510(K)
- K221555Dozee VS2Cleared 510(K)
- K223246Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense2Cleared 510(K)
- K220111RespiraSense2Cleared 510(K)
- K211387Breathe Easy Mobile Respiratory Monitor (MRM)2Cleared 510(K)
- K202018Hill-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 Activation2Cleared 510(K)
- K200445The C100 Contactless Breathing Monitor2Cleared 510(K)
- K190734Linshom Respiratory Monitoring Device (LRMD)2Cleared 510(K)
- K190775The RHEA Vital Sign Vigilance System2Cleared 510(K)
- K173976Masimo Acoustic Respiration Sensors, infant and neonate2Cleared 510(K)
- K180079Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation2Cleared 510(K)
- K171836EarlySense Bed Sensing Unit2Cleared 510(K)
- K152911EarlySense Insight Sytem2Cleared 510(K)
- K151940Thora-3Di, Model T-012Cleared 510(K)
- K133661CHAIR SENSING UNIT FOR EARLYSENSE SYSTEM2Cleared 510(K)
- K132320INTELLIVUE CL RESPIRATION POD2Cleared 510(K)
- K130570NEUROVISION MEDICAL MOTION SENSOR2Cleared 510(K)
- K131379EARLYSENSE2Cleared 510(K)
- K122223NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO2Cleared 510(K)
- K120465EARLYSENSE (EVERON) SYSTEM2Cleared 510(K)
- K111933COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.02Cleared 510(K)
- K103631SLEEPMINDER BREATHING FREQUENCY INDICATOR2Cleared 510(K)
- K100773KAI SPOT MODEL KMS 2002Cleared 510(K)
- K092062EVERON 1.02Cleared 510(K)
- K092685PNEUMOTHERML, MODEL: 58002Cleared 510(K)
- K090273KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 1002Cleared 510(K)
- K082465EVERON2Cleared 510(K)
- K080922SALTER LABS ORAL/NASAL THERMAL AIRFLOW SENSOR2Cleared 510(K)
- K070375EARLYSENSE ES-16 SYSTEM2Cleared 510(K)
- K062883GEREONICS ULTRA-PIEZO LIMB MOVEMENT SENSOR2Cleared 510(K)
- K051779ANDROFLOW - RESPIRATORY RATE MONITOR2Cleared 510(K)
- K040605DYMEDIX REUSABLE RESPIRATORY EFFORT BELT SENSOR, MODEL 6015 AND DYMEDIX REUSABLE LIMB MOVEMENT SENSOR, MODEL 31002Cleared 510(K)
- K003704OPTOVENT RESPONS, OPTOVENT RENEE (OPTOVENT RESPONS WITHOUT PULSE OXIMETRY MODULE)2Cleared 510(K)
- K001743ULTIMA SMARTBELT, MODEL 05602Cleared 510(K)
- K001030RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S2Cleared 510(K)
- K991411GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR2Cleared 510(K)
- K983449GEREONICS ULTRA-PIEZO RESPIRATORY EFFORT SENSOR2Cleared 510(K)
- K981725OPTOVENT RESPIRATORY MONITOR MODEL NUMBER RR 97002Cleared 510(K)
- K984431ULTIMA AIRFLOW PRESSURE SENSOR2Cleared 510(K)
- K982550BROWSER (EVENT SOFTWARE) MODEL # 4500E2Cleared 510(K)
- K981445ULTIMA AIRFLOW SENSOR, 05102Cleared 510(K)
- K982216ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 05222Cleared 510(K)
- K981728ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H1342Cleared 510(K)
- K961972MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR2Cleared 510(K)
- K962781COROMETRICS MODEL 510 AND 511 MONITOR2Cleared 510(K)
- K960851THERMISTOR CANNULA STYLE,SINGLE ELEMENT,ADAM SHELL THERMISTOR AIRFLOW SENSOR2Cleared 510(K)
- K953363OXIFLOW DIGITAL RECORDER2Cleared 510(K)
- K943308MODEL 510 INFANT MONITOR2Cleared 510(K)
- K942170MODEL 511 INFANT MONITOR2Cleared 510(K)
- K941759SNORING SENSOR2Cleared 510(K)
- K940014PLM SENSOR, MODEL PLM12Cleared 510(K)
- K924875MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS2Cleared 510(K)
- K935518MOVING IMAGES(TM)2Cleared 510(K)
- K932902MAGNUM2Cleared 510(K)
- K930790ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.2Cleared 510(K)
- K923737MODEL MEDILOG RAPIDE2Cleared 510(K)
- K921819EDENTEC MODEL 3710 I DIGITAL PRINTER2Cleared 510(K)
- K925364MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES2Cleared 510(K)
- K923402CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR2Cleared 510(K)
- K922112EASYFLOW2Cleared 510(K)
- K913749EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 31702Cleared 510(K)
- K911874SLEEPTRACE 20002Cleared 510(K)
- K911386SLEEPMASTER2Cleared 510(K)
- K912415MEDICAL SAFETY CABLE AND LEAD SYSTEM2Cleared 510(K)
- K904432SLEEP I/T-5 AND SLEEP I/T-82Cleared 510(K)
- K905575MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON2Cleared 510(K)
- K905520MICROTRAPPER/MICRODIGITRAPPER, MODIFICATION2Cleared 510(K)
- K903020RESPIRATION/HEART RATE MONITOR MODEL 9500/95502Cleared 510(K)
- K903011RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL2Cleared 510(K)
- K904396SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM2Cleared 510(K)
- K903300RESP-EZ(TM) RESPIRATORY MONITORING BELT2Cleared 510(K)
- K903287MODEL 900S APNEA/HEART MONITOR2Cleared 510(K)
- K900264R-BAND(TM) RESPIRATORY SENSOR2Cleared 510(K)
- K884120TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)2Cleared 510(K)
- K902785MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON2Cleared 510(K)
- K901656MODEL 9200 RESPIRATION/HEART RATE MONITOR2Cleared 510(K)
- K896934KNIGHTWATCH SYSTEM2Cleared 510(K)
- K900730ARVEE APNEA MONITOR, MODEL 48002Cleared 510(K)
- K901466MESAMIV RECORDER2Cleared 510(K)
- K900826'APNEA-ELECTRODE'2Cleared 510(K)
- K894641MESAM RECORDER2Cleared 510(K)
- K891486AR-800PA RESPIRATION MODULE2Cleared 510(K)
- K891676ARVEE APNEA MONITOR, MODEL 24002Cleared 510(K)
- K883158RESPIRATORY AIRWAY TUBE MONITOR (RATM)2Cleared 510(K)
- K884637MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR2Cleared 510(K)
- K882377HEALTH-WATCH BED MONITOR2Cleared 510(K)
- K880725SAM(TM) MODEL ONE2Cleared 510(K)
- K8627478800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS2Cleared 510(K)
- K881266MODEL 9216 RESPIRATION/HEART RATE MONITOR2Cleared 510(K)
- K872833BREATHGUARD APNEA MONITOR2Cleared 510(K)
- K874898CM 3000 THE MONITOR2Cleared 510(K)
- K874814HEALTHDYNE RATE METER2Cleared 510(K)
- K873791MODEL 500E INFANT MONITORING SYSTEM2Cleared 510(K)
- K871813VITALOG PMS-8 (MODIFICATION)2Cleared 510(K)
- K872631INFANT MONITOR, MODEL 24002Cleared 510(K)
- K872954MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR2Cleared 510(K)
- K871576ROKONICS 85002Cleared 510(K)
- K871551MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR2Cleared 510(K)
- K871302MODEL 2000W OPTION H CONFIGURATION2Cleared 510(K)
- K870835ADULT APNEA MONITOR (20), MONITOR INTERFACE (30)2Cleared 510(K)
- K864261MODEL 3500 INFANT RESPIRATION & HEART RATE MONITOR2Cleared 510(K)
- K864419LIFEWATCH(R) PORTABLE MONITORING SYSTEM2Cleared 510(K)
- K870661LIFEWATCH PLUS2Cleared 510(K)
- K862462LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC2Cleared 510(K)
- K864487LIFEWATCH SENSOR BELT2Cleared 510(K)
- K852249KONTRON VITALMON 5010 PATIENT MONITOR2Cleared 510(K)
- K863612MONAGHAN RVM, MODEL 760 AND 7612Cleared 510(K)
- K862962APNET RESPIRATION MONITOR2Cleared 510(K)
- K861326RESPISOMNOGRAPH2Cleared 510(K)
- K854333BIOCHEM 515 RESPIRATION MONITOR2Cleared 510(K)
- K861484INFANT MONITOR2Cleared 510(K)
- K861423DEMAND OXYGEN SAVER SYSTEM (D02S)2Cleared 510(K)
- K861407NEO-TRAK 502 INFANT MONITOR2Cleared 510(K)
- K861743AS165 RESPIRATION MONITOR2Cleared 510(K)
- K854705INFAGUARD TM2Cleared 510(K)
- K854355GREENLEAF SMART POLYGRAPH PROGRAM2Cleared 510(K)
- K860455MODEL 9000 RECORDING SYSTEM/RESPIRATION MONITORING2Cleared 510(K)
- K860254HEALTHDYNE'S EVENT RECORDER SYSTEM2Cleared 510(K)
- K853252EMERGENT TECHNOLOGY VENTILATORY EFFORT MONITOR VEM2Cleared 510(K)
- K851819ROKONICS SENTRY MODEL 85002Cleared 510(K)
- K853047MONAGHAN RVM, MODEL 760 OR MODEL 7612Cleared 510(K)
- K851889CENTURION-II, MODEL 3103 APNEA/BRADY CARDIA TRACHY2Cleared 510(K)
- K853303LIFELINC LEADWIRE2Cleared 510(K)
- K853452LIFE LINC PATIENT CABLE2Cleared 510(K)
- K853084MEDICON MODEL 8200 AMS(APNEA MONITOR SYSTEM)2Cleared 510(K)
- K844327EDENTEC MODEL 2000W APNEA MONITOR2Cleared 510(K)
- K852515ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR2Cleared 510(K)
- K850504COROMETRICS 500 INFANT MONITOR2Cleared 510(K)
- K841392BIOMATT-12Cleared 510(K)
- K843681RESPIRATION & HEART RATE MONITOR 5302Cleared 510(K)
- K842048SUN-ONE2Cleared 510(K)
- K843546INFANT MONITOR 169002Cleared 510(K)
- K840488LIFECYCLE AEROBIC MONITOR 1232Cleared 510(K)
- K831601APNEA ALARM FOR ADULT-PEDIATRIC & NEON2Cleared 510(K)
- K831650ANESTHESIA/RESPIRATORY DISCONNECT -2Cleared 510(K)
- K823563EEG & RESPIRATION MODULES POLYGRAPH2Cleared 510(K)
- K822819TRIMED 510 APNEA MONITOR2Cleared 510(K)
- K821731HEALTHDYNE MODEL 16900 INFANT MONITOR2Cleared 510(K)
- K820778RESPIRATION MONITOR 10002Cleared 510(K)
- K820645INFANT MONITOR2Cleared 510(K)
- K820374JLS GROUP INFANT MONITOR2Cleared 510(K)
- K813507INFALERT2Cleared 510(K)
- K812873MEDICON #8200 AMS2Cleared 510(K)
- K812667MEDDARS/ULTRA IMAGER RESPIRATION MODULE2Cleared 510(K)
- K812045INFANT APNEA MONITOR MODEL 1002Cleared 510(K)
- K812044RESPIRATION RATE MONITOR 120/1212Cleared 510(K)
- K811865VMA PEDIATRIC APNEA MATTRESS2Cleared 510(K)
- K811628OECO APNEA MONITOR2Cleared 510(K)
- K811265RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)2Cleared 510(K)
- K811014RESPIRATORY SENSOR2Cleared 510(K)
- K810175NEO NATAL RESPIRATION FUNCTION BLOCK2Cleared 510(K)
- K810174RESPIRATION FUNCTION BLOCKS2Cleared 510(K)
- K802205ECG/RESPIRATION STIMULATOR2Cleared 510(K)
- K802046PDS MODEL 3000 ADULT RESPIRATION MODULE2Cleared 510(K)
- K801894RESPONDER II2Cleared 510(K)
- K792528RESPIRATION/APNEA AMPLIFIER MODEL 31052Cleared 510(K)
- K790304PREAMPLIFIER MODULE, EKG RESPIRATION2Cleared 510(K)
- K782044MONITOR HS82Cleared 510(K)
- K782045MONITOR HS72Cleared 510(K)
- K781158ALARM UNIT, BATTERY OPERATED2Cleared 510(K)
- K781515MODEL LS-80 ADULT VENTILATION MONITOR2Cleared 510(K)
- K771407LUNG VOLUME & PRESSURE MONITOR2Cleared 510(K)
- K771019LUNG-MECHANICS MONITOR2Cleared 510(K)
- K770250GOWN, SURGICAL, SURGINE2Cleared 510(K)
- K760339MONITOR, RESPIRATORY (CPAP)2Cleared 510(K)
- K760340RESPIRATORY SUPPORT SYSTEM, NEONATAL2Cleared 510(K)
- CANRegulator, Pressure, Gas Cylinder1Product Code
- CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)2Product Code
- CAXFlowmeter, Tube, Thorpe, Back-Pressure Compensated1Product Code
- CBAMonitor, Air Embolism, Ultrasonic2Product Code
- CCNFlowmeter, Nonback-Pressure Compensated, Bourdon Gauge1Product Code
- ECXCylinder, Compressed Gas, And Valve1Product Code
- FLSMonitor, Apnea, Facility Use2Product Code
- JAXPneumotachometer2Product Code
- JEZMonitor, Lung Water Measurement3Product Code
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia2Product Code
- KOIStimulator, Nerve, Peripheral, Electric2Product Code
- LKDMonitor, Carbon-Dioxide, Cutaneous2Product Code
- LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia2Product Code
- MNRVentilatory Effort Recorder2Product Code
- MRPAnalyzer, Nitric Oxide2Product Code
- MRQAnalyzer, Nitrogen Dioxide2Product Code
- NPFMonitor, Apnea, Home Use2Product Code
- PRKDevice Indicating An Exhalation Event2Product Code
- PUGAnalyzer, Nitrogen Dioxide, Exempt2Product Code
- PXEPressure Monitoring (Air/Gas) Kit1Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
EarlySense Insight Sytem
- Page Type
- Cleared 510(K)
- 510(k) Number
- K152911
- 510(k) Type
- Traditional
- Applicant
- EarlySense Ltd.
- Country
- Israel
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/6/2016
- Days to Decision
- 217 days
- Submission Type
- Summary