Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—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
- 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
- K231667Withings Sleep Rx2Cleared 510(K)
- K233501“LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A)2Cleared 510(K)
- K240285Huxley SANSA Home Sleep Apnea Test (1000-00)2Cleared 510(K)
- K240100SAM Model 9-100002Cleared 510(K)
- K231355Aurora2Cleared 510(K)
- K231546Somfit2Cleared 510(K)
- K223573Onera Sleep Test System (Onera STS)2Cleared 510(K)
- K221816Wesper Lab2Cleared 510(K)
- K222579Belun Sleep System BLS-1002Cleared 510(K)
- K222950AcuPebble OX1002Cleared 510(K)
- K223675WatchPAT ONE (WP1)2Cleared 510(K)
- K220012BresoDX12Cleared 510(K)
- K222331WatchPAT300 (WP300)2Cleared 510(K)
- K220095ANNE Sleep2Cleared 510(K)
- K213360SleepCheckRx2Cleared 510(K)
- K210593Onera Sleep Test System (Onera STS)2Cleared 510(K)
- K203839WatchPAT200U (WP200U)2Cleared 510(K)
- K220028NightOwl2Cleared 510(K)
- K203343Wesper Lab2Cleared 510(K)
- K213463NightOwl2Cleared 510(K)
- K210480AcuPebble SA2Cleared 510(K)
- K201495Maxxi Flow Sensor2Cleared 510(K)
- K200695MATRx plus2Cleared 510(K)
- K200654Rubicon SA System2Cleared 510(K)
- K191031NightOwl2Cleared 510(K)
- K191095Maxxi Snore Sensor2Cleared 510(K)
- K191925MATRx Plus2Cleared 510(K)
- K183625SomnaPatch2Cleared 510(K)
- K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant2Cleared 510(K)
- K182618SleepImage System2Cleared 510(K)
- K173974DROWZLE2Cleared 510(K)
- K171304Maxxi Rip Sensor2Cleared 510(K)
- K183559WatchPAT ONE2Cleared 510(K)
- K173793XactTrace Single Use Respiratory Effort Belt System2Cleared 510(K)
- K181996MATRx Plus2Cleared 510(K)
- K180775Watch-PAT3002Cleared 510(K)
- K172799Positional Sleep Assessment System (PoSAS) software2Cleared 510(K)
- K163696SleepImage System2Cleared 510(K)
- K163665MATRx plus2Cleared 510(K)
- K160499Apnea Risk Evaluation System (ARES), Model 6202Cleared 510(K)
- K161579Watch-PAT200U2Cleared 510(K)
- K153070Watch-PAT200U2Cleared 510(K)
- K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal2Cleared 510(K)
- K151433AUDICOR CA300/CC100 Analyzer with SDB2Cleared 510(K)
- K151361Nox RIP Belts & Cables2Cleared 510(K)
- K150102SnoreSounds2Cleared 510(K)
- K143272ApneaLink Air2Cleared 510(K)
- K140861SOMNOTOUCH RESP2Cleared 510(K)
- K133859WATCH-PAT200U (WP200U)2Cleared 510(K)
- K131883AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)2Cleared 510(K)
- K131932APNEALINK PRO2Cleared 510(K)
- K131994SOMNOLYZER 24X72Cleared 510(K)
- K124062QDC-PRO, AND NOX-RIP2Cleared 510(K)
- K122516EMBLETTA MPR2Cleared 510(K)
- K112514APNEA RISK EVALUATION SYSTEM (ARES)2Cleared 510(K)
- K112822SLEEPSTRIP II2Cleared 510(K)
- K112102MICHELE SLEEP SCORING SYSTEMS2Cleared 510(K)
- K111742MDRIVE2Cleared 510(K)
- K111314MORPHEUS OX2Cleared 510(K)
- K110486ACCUSOM2Cleared 510(K)
- K111194APNEA RISK EVALUATION SYSTEM (ARES)2Cleared 510(K)
- K102567WATCH-PAT 200S-3 (WP200S-3)2Cleared 510(K)
- K110705APNEA RISK EVALUATION SYSTEM (ARES)2Cleared 510(K)
- K110064SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM2Cleared 510(K)
- K092003CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE2Cleared 510(K)
- K090484ALICE PDX2Cleared 510(K)
- K090958INOMAX DS (DELIVERY SYSTEM)2Cleared 510(K)
- K082853CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR2Cleared 510(K)
- K083575APNEALINK PLUS, MODEL: 223282Cleared 510(K)
- K083620SOMNOLYZER 24X72Cleared 510(K)
- K083874GALAXY2Cleared 510(K)
- K082968APNEICARE CONNECTION CENTER/INTERNET ANALYSIS2Cleared 510(K)
- K081861HOLTER LX ANALYSIS2Cleared 510(K)
- K082113NOX T3, NOXTURNAL (PC APPLICATION)2Cleared 510(K)
- K081485SOMNOWATCH2Cleared 510(K)
- K080375RMX PHYSIOLOGICAL DATA RECORDER2Cleared 510(K)
- K081982WATCH-PAT 200S-2 (WP200S-2)2Cleared 510(K)
- K073682EMBLETTA GOLD2Cleared 510(K)
- K080983PROVENT NASAL CANNULA2Cleared 510(K)
- K081176FLOCHANNEL2Cleared 510(K)
- K081037WATCH-PAT 200I (WP200I)2Cleared 510(K)
- K080427WATCH-PAT MODEL 100S-22Cleared 510(K)
- K080321SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM2Cleared 510(K)
- K073269HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM2Cleared 510(K)
- K072201COMPUMEDICS SOMTE PSG RECORDING SYSTEM2Cleared 510(K)
- K070855SLEEP QUALITY2Cleared 510(K)
- K072014VITASCORE2Cleared 510(K)
- K071230APNEA RISK EVALUATION SYSTEM (ARES), MODEL 6002Cleared 510(K)
- K071556SOMNOSCREEN EEG10-202Cleared 510(K)
- K070263APNEALINK2Cleared 510(K)
- K070326NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K060708SOMNOSCREEN2Cleared 510(K)
- K061705CADWELL EASYNET NASAL PRESSURE MODULE2Cleared 510(K)
- K061996SANDMAN POCKET2Cleared 510(K)
- K061764MEDIBYTE, MODEL MP82Cleared 510(K)
- K061405APNEALINK, MODEL 223022Cleared 510(K)
- K052573STARDUST II2Cleared 510(K)
- K051313BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER2Cleared 510(K)
- K042745LIFESCREEN APNEA2Cleared 510(K)
- K042916WATCH PAT 100S2Cleared 510(K)
- K043132UNIVERSAL XACTTRACE2Cleared 510(K)
- K041662APNEA RISK EVALUATION SYSTEM (ARES)2Cleared 510(K)
- K042253SLEEPSENSE SLEEP SENSORS2Cleared 510(K)
- K041724COMPASS M10 SYSTEM2Cleared 510(K)
- K041904COMPASS F10 SYSTEM2Cleared 510(K)
- K040576MICROMESAM BASIC-SET2Cleared 510(K)
- K033402PORTABLE SLEEP DATA RECORDER (PSDR)2Cleared 510(K)
- K021845STARDUST II, MODEL 10111762Cleared 510(K)
- K040069DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR2Cleared 510(K)
- K040194COMPUMEDICS SUMMIT IP2Cleared 510(K)
- K024322EMBLA N70002Cleared 510(K)
- K030379APLAB, MODEL 801D00302Cleared 510(K)
- K022506MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM2Cleared 510(K)
- K022294APNEACHECK2Cleared 510(K)
- K030611MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM2Cleared 510(K)
- K021138SLEEPSCREEN/APNOESCREEN CARDIO2Cleared 510(K)
- K021176COMPUMEDICS SOMTE SYSTEM2Cleared 510(K)
- K020607SLEEPFLO, MODEL 1015012Cleared 510(K)
- K020312ULTIMA SNORING MIKE, MODEL 05402Cleared 510(K)
- K012437DEVILBISS SLEEP RECORDER MODEL # RM602Cleared 510(K)
- K002159SNORE SAT RECORDER, MODEL SS412Cleared 510(K)
- K010156SLEEP PAT 200 DEVICE2Cleared 510(K)
- K013905MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS2Cleared 510(K)
- K010739WATCH-PAT 1002Cleared 510(K)
- K002095SNAP MODEL 62Cleared 510(K)
- K000396APNOESCREEN PRO, ALPHA SCREEN PRO2Cleared 510(K)
- K002135SLEEPSTRIP DISPOSABLE APNEA SCREENER2Cleared 510(K)
- K000253SILENT NIGHT V2Cleared 510(K)
- K992322SNAP MODEL 52Cleared 510(K)
- K990565SUZANNE2Cleared 510(K)
- K990321ALPHAMED GEMINI SENSOR, SNORING SENSOR2Cleared 510(K)
- K984169DIGI-SNAP2Cleared 510(K)
- K990199SMARTRECORDER, MODEL 25002Cleared 510(K)
- K983572SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 55002Cleared 510(K)
- K981034SILENT NIGHT II2Cleared 510(K)
- K982293PRESSURE TRANSDUCER AIRFLOW SENSOR2Cleared 510(K)
- K973920STARDUST2Cleared 510(K)
- K971803NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 1012Cleared 510(K)
- K971501SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER2Cleared 510(K)
- K971184OXI-SNAP2Cleared 510(K)
- K955841SLEEP SYSTEM FOR CLINICS & RESEARCH2Cleared 510(K)
- K964494SLEEPWIZARD2Cleared 510(K)
- K963597SILENT NIGHT I2Cleared 510(K)
- K962103BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER2Cleared 510(K)
- K944524SNAP TESTING DEVICE2Cleared 510(K)
- K950273SLEEP TEST(TM)2Cleared 510(K)
- K940013BODY POSITION INDICATOR, MODEL BPI12Cleared 510(K)
- K944611MODEL# 7500 SURVEYOR2Cleared 510(K)
- K940015SNORING MICROPHONE, SM12Cleared 510(K)
- 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
NightOwl
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K191031
- 510(k) Type
- Traditional
- Applicant
- Ectosense nv
- Country
- Belgium
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/6/2020
- Days to Decision
- 323 days
- Submission Type
- Summary