Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- DQDStethoscope, Electronic2Product Code
- K252595Stethophone Pro2Cleared 510(K)
- K251494Eko Foundation Analysis Software with Transformers (EFAST)2Cleared 510(K)
- K242971AccurSound Electronic Stethoscope (AS101)2Cleared 510(K)
- K240901Stethophone2Cleared 510(K)
- K233313Keikku Electronic stethoscope2Cleared 510(K)
- K233609CORE 500 Digital Stethoscope2Cleared 510(K)
- K231551Stethophone2Cleared 510(K)
- K230613SKEEPER2Cleared 510(K)
- K230823AusculThing ACC2Cleared 510(K)
- K230111CORE 500 Digital Stethoscope2Cleared 510(K)
- K230769PrevisEA Device2Cleared 510(K)
- K223785N9+2Cleared 510(K)
- K222871Stethophone v12Cleared 510(K)
- K221805AccurSound Electronic Stethoscope AS-1012Cleared 510(K)
- K212906HeartBuds Electronic Stethoscope2Cleared 510(K)
- K223166Medaica M1 Telehealth Stethoscope2Cleared 510(K)
- K220466ibiomedi Electronic Stethoscope ES-20202Cleared 510(K)
- K220099eClinic Stethopod2Cleared 510(K)
- K213794Eko Murmur Analysis Software (EMAS)2Cleared 510(K)
- K220766eMurmur Heart AI2Cleared 510(K)
- K211779ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine.2Cleared 510(K)
- K220470Smart Wireless Stethoscope2Cleared 510(K)
- K220196Steth IO Spot2Cleared 510(K)
- K212709VoqX Electronic Stethoscope2Cleared 510(K)
- K212013eKuore Pro 4T - REF EP00982Cleared 510(K)
- K211068PrevisEA Device2Cleared 510(K)
- K210736doctorgram Stethoscope DES-I2Cleared 510(K)
- K202483MyHomeDoc2Cleared 510(K)
- K201742eKuore One Wireless Electronic Interface for stethoscope2Cleared 510(K)
- K203007eKuore Pro Series2Cleared 510(K)
- K193631Stethee Pro 1, Stethee Pro Software System2Cleared 510(K)
- K200862Feelix Stethoscope2Cleared 510(K)
- K201299HD Steth2Cleared 510(K)
- K200776Eko CORE2Cleared 510(K)
- K191667Electronic Stethoscope2Cleared 510(K)
- K183710Vivio System2Cleared 510(K)
- K181988eMurmur ID2Cleared 510(K)
- K181882eKuore One electronic interface for stethoscope2Cleared 510(K)
- K181612Tyto Stethoscope (OTC)2Cleared 510(K)
- K182196Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth2Cleared 510(K)
- K173663Electronic Stethoscope DS3011A2Cleared 510(K)
- K173448CliniCloud Stethoscope2Cleared 510(K)
- K172296Stethee Pro2Cleared 510(K)
- K170928CADence System2Cleared 510(K)
- K170874Eko Model E5 System (EME5), Eko DUO2Cleared 510(K)
- K162589Adscope 658 Electronic Stethoscope2Cleared 510(K)
- K160401Tyto Stethoscope2Cleared 510(K)
- K160023Electronic Stethoscope DS3012Cleared 510(K)
- K160016Steth IO2Cleared 510(K)
- K150782AbStats Gateway2Cleared 510(K)
- K151319Eko Electronic Stethoscope System2Cleared 510(K)
- K123148PARACE MD EKOSCOPE IS1002Cleared 510(K)
- K132560PCP-USB STETHOSCOPE2Cleared 510(K)
- K132405PPA/BT-RB STETHOSCOPE2Cleared 510(K)
- K131044SENSICARDIAC MOBI DIAGNOSTIC HEART MURMUR APPLICATION2Cleared 510(K)
- K131287CARDIOSLEEVE2Cleared 510(K)
- K121144ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K121617SENSICARDIAC2Cleared 510(K)
- K110704SENSI2Cleared 510(K)
- K103499A SCOPE2Cleared 510(K)
- K103516AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.02Cleared 510(K)
- K102893PCP/PC STETHOSCOPE2Cleared 510(K)
- K100531VISCOPE, MODEL 100P,100S2Cleared 510(K)
- K091972MILSCOPE FLOATING MASS STETHOSCOPE, MODEL 300-012Cleared 510(K)
- K090493SIGNAL2Cleared 510(K)
- K0839033M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 32002Cleared 510(K)
- K082528SNOR-SCOPE PLUS OR SNOR-SCOPE + ELECTRONIC STETHOSCOPE SYSTEM2Cleared 510(K)
- K082771PROTRON TECHNOLOGIES, LLC STETHOTRON2Cleared 510(K)
- K083309ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.332Cleared 510(K)
- K081032TR-USB TELEPHONIC STETHOSCOPE2Cleared 510(K)
- K070550AUSCO ES-31002Cleared 510(K)
- K072026RNK ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K062364I-SCOPE 2002Cleared 510(K)
- K062481SERENO ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K060321ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK2Cleared 510(K)
- K060197ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.282Cleared 510(K)
- K052283HEART STG SYSTEM AND SOFTWARE2Cleared 510(K)
- K051450EXTENDED MEASUREMENTS SYSTEM2Cleared 510(K)
- K050097TECHNO-SCOPE VISUAL STETHOSCOPE2Cleared 510(K)
- K0517903M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 41002Cleared 510(K)
- K050169HL 200 ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K050159MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 30002Cleared 510(K)
- K0419343M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 30002Cleared 510(K)
- K042128MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)2Cleared 510(K)
- K031517ZARGIS ACOUSTIC CARDIOSCAN2Cleared 510(K)
- K034046RNK TELEPHONIC STETHOSCOPE, MODEL TR-12Cleared 510(K)
- K032230RHYTHM DIGITAL ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K031446JABES ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K023759CARDIOVASCULAR SONOSPECTROGRAPHIC ANALYZER2Cleared 510(K)
- K023637TYTAN ELECTRONIC STETHOSCOPES (MODEL #600)2Cleared 510(K)
- K021087HIPPOCRAT ELECTRONIC STETHOSCOPE, MODEL DR300; SOUNDS EASY AUSCULTATION SOFTWARE2Cleared 510(K)
- K022298I-STETHOS LINK2Cleared 510(K)
- K021389BIOLOGICAL SOUND MONITOR (BSM) SENSOR2Cleared 510(K)
- K013725MEDITRON II THESTERTHOSCOPE SYSTEM2Cleared 510(K)
- K012304ADC 656 ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K010729AGILENT ELECTRONIC STETHOSCOPE, MODELS M4532A AND M4533A2Cleared 510(K)
- K011898E-STETH ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K0037233M LITTMANN2Cleared 510(K)
- K003485CARE PROVIDER STATION ADDITION OF WEIGHT SCALE2Cleared 510(K)
- K002984EHC400 DESKTOP PATIENT STATION; EHC600 CARE PROVIDER STATION2Cleared 510(K)
- K002047DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B22Cleared 510(K)
- K001788ESTATION ELECTRONIC STETHOSCOPE, MODEL DR2002Cleared 510(K)
- K001306STETHOS, MODEL STXXYYZZ OR 001 XXX, STETHOS LINK, MODEL SLXXYYZZ OR 002 XXX2Cleared 510(K)
- K993623GEMINI E2Cleared 510(K)
- K9917563 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE2Cleared 510(K)
- K991714DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-002Cleared 510(K)
- K991367MEDITRON STETHOSCOPE SYSTEM2Cleared 510(K)
- K990809CADISCOPE ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K9618483M LITTMANN ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K963418TRANSMEDICA MODEL 100 DIGITAL ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K963678CARETONE II2Cleared 510(K)
- K961937SIMULSCOPE AUSCULTATION AND SIMULSCOPE BEDSIDE AUSCULTATION SYSTEM2Cleared 510(K)
- K963621STETHOS2Cleared 510(K)
- K961857LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-10602Cleared 510(K)
- K961301E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-71202Cleared 510(K)
- K953833LIFE SOUND SENSOR AMPLIFIER-LISA2Cleared 510(K)
- K950760ANALYST, MODEL DSP 3002Cleared 510(K)
- K953218AUSCULATOR GPS2Cleared 510(K)
- K945638TELPHONIC STETHOSCOPE2Cleared 510(K)
- K941763ELECTRONIC-AMPLIFIED STETHOSCOPE2Cleared 510(K)
- K9200093M LITTMANN GRAPHIC DISPLAY SYSTEM2Cleared 510(K)
- K893557ADAM (ACOUSTICAL DEVICE FOR ANATOMICAL MONITORING)2Cleared 510(K)
- K892890STETH-SHIELD(TM)2Cleared 510(K)
- K882716PROCEDURE PACKS SOLUTION ADMINISTRATION SETS2Cleared 510(K)
- K874726MASCOT STETHOSCOPE PROBE2Cleared 510(K)
- K870810DORCHES(TM) LIFESOUND(TM)2Cleared 510(K)
- K864278DS-II DIGITAL SONOGRAPHY SYSTEM2Cleared 510(K)
- K860994DECITEL AUSCULSCOPE2Cleared 510(K)
- K854772TRANSCOR (TM) RADIO-STETHOSCOPE2Cleared 510(K)
- K854356STETHOSCOPE ELECTRONIC STETHOSCOPE SPHYGMOMANOMETE2Cleared 510(K)
- K844804LIFESOUND - ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K842705MX2 ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K831763MAX I2Cleared 510(K)
- K832882DIF-STET2Cleared 510(K)
- K812148ELECTRONIC STETHOSCOPE #S-502Cleared 510(K)
- K801189CONPHAR SUPERTONE STETHOSCOPE2Cleared 510(K)
- K801165HYPERSTETHOSCOPE, MODEL Z 002Cleared 510(K)
- K792112CONPHAR STETHSCOPE2Cleared 510(K)
- K791334MULTISCOPE2Cleared 510(K)
- K791338DUAL HEAD STETHOSCOPE2Cleared 510(K)
- K791335NURSESCOPE2Cleared 510(K)
- K791333BOWLES STETHOSCOPE2Cleared 510(K)
- K780738PENTAX ST-1A2Cleared 510(K)
- K772173STETHOSCOPE, ELECTRONIC2Cleared 510(K)
- K771520ESOPHAGEAL STETHOSCOPE2Cleared 510(K)
- K771653ELECTRONIC STETHOSCOPE2Cleared 510(K)
- K771581STETHOSCOPE, NURSESCOPE TYPE2Cleared 510(K)
- K771505STETHOSCOPE2Cleared 510(K)
- K771506STETHOSCOPE2Cleared 510(K)
- K771504STETHOSCOPE2Cleared 510(K)
- DQECatheter, Oximeter, Fiber-Optic2Product Code
- DQGMicrosphere, Trace3Product Code
- DQKComputer, Diagnostic, Programmable2Product Code
- DQOCatheter, Intravascular, Diagnostic2Product Code
- DQPKit, Balloon Repair, Catheter3Product Code
- DQRCannula, Catheter2Product Code
- DQTOccluder, Catheter Tip2Product Code
- DQXWire, Guide, Catheter2Product Code
- DQYCatheter, Percutaneous2Product Code
- DRACatheter, Steerable2Product Code
- DRBStylet, Catheter2Product Code
- DRCTrocar2Product Code
- DREDilator, Vessel, For Percutaneous Catheterization2Product Code
- DRFCatheter, Electrode Recording, Or Probe, Electrode Recording2Product Code
- DSIDetector And Alarm, Arrhythmia2Product Code
- DSJAlarm, Blood-Pressure2Product Code
- DSKComputer, Blood-Pressure2Product Code
- DXGComputer, Diagnostic, Pre-Programmed, Single-Function2Product Code
- DXLInjector, Indicator2Product Code
- DXMDensitometer2Product Code
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive2Product Code
- DXQBlood Pressure Cuff2Product Code
- DXWSystem, Phonocatheter, Intracavitary2Product Code
- DXXSystem, Catheter Control, Steerable2Product Code
- DYBIntroducer, Catheter2Product Code
- DYGCatheter, Flow Directed2Product Code
- JOQGenerator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)2Product Code
- KRACatheter, Continuous Flush2Product Code
- KRBProbe, Thermodilution2Product Code
- KRKManometer, Blood-Pressure, Venous2Product Code
- LDEStethoscope, Manual1Product Code
- LITCatheter, Angioplasty, Peripheral, Transluminal2Product Code
- MAVSyringe, Balloon Inflation2Product Code
- MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)2Product Code
- MLDMonitor, St Segment With Alarm2Product Code
- MTDCatheter, Intracardiac Mapping, High-Density Array2Product Code
- MXDRecorder, Event, Implantable Cardiac, (With Arrhythmia Detection)2Product Code
- NFATemporary Coronary Saphenous Vein Bypass Graft For Embolic Protection2Product Code
- NKQGuidewire, Catheter, Reprocessed2Product Code
- NKRSystem, Catheter Control, Reprocessed2Product Code
- NKSCatheter, Steerable, Reprocessed2Product Code
- NKUInjector And Syringe, Angiographic, Balloon Inflation, Reprocessed2Product Code
- NKWActuator, Syringe, For Injector, Reprocessed2Product Code
- NLGCatheter, Intracardiac Mapping, High-Density, Reprocessed2Product Code
- NLHCatheter, Recording, Electrode, Reprocessed2Product Code
- NLICatheter, Angiography, Reprocessed2Product Code
- NMBCatheter, Oximeter, Fiber Optic, Reprocessed2Product Code
- NMKTrocar, Reprocessed2Product Code
- NMMCatheter, Angioplasty, Peripheral, Transluminal, Reprocessed2Product Code
- NPPReprocessed Blood Pressure Cuff2Product Code
- NTETemporary Carotid Catheter For Embolic Capture2Product Code
- NVMCatheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon2Product Code
- OBICatheter, Pressure Monitoring, Cardiac2Product Code
- OBJCatheter, Ultrasound, Intravascular2Product Code
- OEDAntimicrobial Blood Pressure Cuff2Product Code
- OEQAngiography/Angioplasty Kit2Product Code
- OERAngioscopic Valvulotome Kit2Product Code
- OESCardiac Catheterization Kit2Product Code
- OEXCardiovascular Catheter Sheath Introducer Kit2Product Code
- OEZCardiovascular Procedure Kit2Product Code
- OFBCatheter Guide Wire Kit2Product Code
- OFCCatheter Introducer Kit2Product Code
- OFDCatheter Introducer Kit2Product Code
- OFECentral Venous Blood Pressure Kit2Product Code
- OMZPulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter2Product Code
- OFFCentral Venous Catheter Tray2Product Code
- OFHDigital Angiography Tray2Product Code
- ORDOptical Coherence Tomography, Intravascular Catheter2Product Code
- OFJLead Introducer Kit2Product Code
- OFKPercutaneous Atrial Catheter Kit2Product Code
- OFLPercutaneous Sheath Introducer Kit2Product Code
- OFNWinged Intravenous Catheterization Kit2Product Code
- OGZCatheter, Intravascular, Plaque Morphology Evaluation2Product Code
- OWQReprocessed Intravascular Ultrasound Catheter2Product Code
- OZTBalloon Aortic Valvuloplasty2Product Code
- PDUCatheter For Crossing Total Occlusions2Product Code
- PFANon-Invasive Central Venous Manometer2Product Code
- PJACoronary Vascular Physiologic Simulation Software2Product Code
- PNEReprocessed Catheter Introducer2Product Code
- PNOCatheter, Percutaneous, Cutting/Scoring2Product Code
- PPNPercutaneous Catheter, Ultrasound2Product Code
- PQKPercutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access2Product Code
- PTLWire, Guide, Catheter, Exempt2Product Code
- PTMSyringe, Balloon Inflation, Exempt2Product Code
- PUMTemporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures2Product Code
- QEKAngiographic Coronary Vascular Physiologic Simulation Software2Product Code
- QFJIntravascular Bleed Monitor2Product Code
- QJHReverse Central Venous Recanalization System2Product Code
- QMWCoronary Artery Disease Risk Indicator From Acoustic Heart Signals2Product Code
- QQIInterventional Cardiovascular Implant Simulation Software Device2Product Code
- QYFNeonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms)2Product Code
- QYWHospital Cardiac Telemetry2Product Code
- QYXOutpatient Cardiac Telemetry2Product Code
- NPGCatheter, Infusion, Syringe2Product Code
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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Stethee Pro 1, Stethee Pro Software System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K193631
- 510(k) Type
- Traditional
- Applicant
- M3DICINE Pty Ltd.
- Country
- Australia
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/9/2020
- Days to Decision
- 287 days
- Submission Type
- Summary