Anesthesiology
Review Panel
- CardiovascularReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- DSMAlarm, Leakage Current, Portable1Product Code
- DPSElectrocardiograph2Product Code
- DPTProbe, Blood-Flow, Extravascular2Product Code
- DPWFlowmeter, Blood, Cardiovascular2Product Code
- DQBPhlebograph, Impedance2Product Code
- DQCPhonocardiograph1Product Code
- DQHCardiograph, Apex (Vibrocardiograph)2Product Code
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency2Product Code
- DRIMonitor, Line Isolation1Product Code
- DRJSystem, Signal Isolation1Product Code
- DRQAmplifier And Signal Conditioner, Transducer Signal2Product Code
- DRRAmplifier And Signal Conditioner, Biopotential2Product Code
- DRSTransducer, Blood-Pressure, Extravascular2Product Code
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)2Product Code
- DRWAdaptor, Lead Switching, Electrocardiograph2Product Code
- DRXElectrode, Electrocardiograph2Product Code
- DRZOscillometer2Product Code
- DSACable, Transducer And Electrode, Patient, (Including Connector)2Product Code
- DSBPlethysmograph, Impedance2Product Code
- K250634BCM2-Body Composition Monitor2Cleared 510(K)
- K243727Re:Balans2Cleared 510(K)
- K250922Edema Guard Monitor (EGM) CardioSet-0012Cleared 510(K)
- K232089SOZO Pro2Cleared 510(K)
- K223217Zynex Monitoring System, Model CM-16002Cleared 510(K)
- K211585Bodyport Cardiac Scale2Cleared 510(K)
- K203473SOZO2Cleared 510(K)
- K193410SOZO Body Fluid Analyzer2Cleared 510(K)
- K191697Cardiac Monitor 15002Cleared 510(K)
- K180479ReDS System2Cleared 510(K)
- K172431Cardiovascular Analzyer2Cleared 510(K)
- K172507SOZO2Cleared 510(K)
- K172196ECOM™ Cardiac Output Monitoring System2Cleared 510(K)
- K150095ReDs Wearable System2Cleared 510(K)
- K142503IMED-Z FLUID STATUS MONITOR2Cleared 510(K)
- K140102PHYSIOFLOW Q-LINK2Cleared 510(K)
- K133301ZOE FLUID STATUS MONITOR2Cleared 510(K)
- K131765ECOM ENDOTRACHEAL CARDIAC OUTPUT MONITOR SYSTEM2Cleared 510(K)
- K131509ZOE FLUID STATUS MONITOR2Cleared 510(K)
- K112830ZOEFLUID STATUS MONITOR (MODEL ZOE 2B)2Cleared 510(K)
- K110645BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR2Cleared 510(K)
- K103166CHEETAH RELIANT2Cleared 510(K)
- K103283PHYSIOFLOW ENDURO2Cleared 510(K)
- K080941BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM2Cleared 510(K)
- K090602CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS2Cleared 510(K)
- K083093CHEETAH RELIANT2Cleared 510(K)
- K082242ICON, MODEL C32Cleared 510(K)
- K081035AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C22Cleared 510(K)
- K060387PHYSIOFLOW SYSTEM2Cleared 510(K)
- K070985AESCULON CHF, HYPERTENSION & PACEMAKER CLINIC2Cleared 510(K)
- K072662CHEETAH RELIANT, CHEETAH ACTIVE2Cleared 510(K)
- K070156BIOZ DX HEMODYNAMIC MONITOR WITH PHILIPS 12-LEAD ECG, MODEL 51002Cleared 510(K)
- K070500BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM2Cleared 510(K)
- K051228BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG2Cleared 510(K)
- K041294BIOZDX HEMODYNAMIC MONITOR2Cleared 510(K)
- K042113ZOE FLUID STATUS MONITOR2Cleared 510(K)
- K041434C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS2Cleared 510(K)
- K032491ECOM CV4 ENDOTRACHEAL CARDIAC OUTPUT MONITOR2Cleared 510(K)
- K021174ECOM ENDOTRACHIAL CARDIAC OUTPUT MONITOR2Cleared 510(K)
- K014063TASK FORCE MONITOR 30402Cleared 510(K)
- K014299SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH2Cleared 510(K)
- K011439MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR2Cleared 510(K)
- K011797BIOZTECT SENSOR AND BIOZTECT CABLE2Cleared 510(K)
- K010164ICG MODULE2Cleared 510(K)
- K001081BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-8102Cleared 510(K)
- K001100BIOZ.COM HEMODYNAMIC MONITOR WITH BIOZ TECT SENSOR AND BIOZ TECT CABLE IMPEDANCE PLETHYSMOGRAPH2Cleared 510(K)
- K981720IQ SYSTEM2Cleared 510(K)
- K974725BIOZ.COM SYSTEM2Cleared 510(K)
- K974621PERCUPUMP II WITH EDA2Cleared 510(K)
- K962783EDEMA SYSTEM2Cleared 510(K)
- K972320BIOZ SYSTEM & BIOZ PORTABLE2Cleared 510(K)
- K952172HOTMAN2Cleared 510(K)
- K970603D SERIES ELECTRODE2Cleared 510(K)
- K961845PERCUPUMP II WITH EDA2Cleared 510(K)
- K963183BIOZ SYSTEM2Cleared 510(K)
- K942227NICAS 2001 NONINVASIVE CARDIO-RESPIRATORY SYSTEM2Cleared 510(K)
- K922601FUTREX-5000A2Cleared 510(K)
- K922600FUTREX-50002Cleared 510(K)
- K951097BODYSTAY2Cleared 510(K)
- K950389SORBA MODEL CIC-1000 NON-INVASIVE HEMODYNAMIC MONITOR2Cleared 510(K)
- K941162HYPERGRAPH2Cleared 510(K)
- K930599BODY FAT ANALYZER MODEL TBF-1052Cleared 510(K)
- K932438MODEL IPM-1 IMPEDANCE PULSE MONITOR2Cleared 510(K)
- K910994MODIFIED SEISMOCARDIOGRAPH2Cleared 510(K)
- K914200VASCUMAP MEDICAL AIR PLETHYSMOGRAPH2Cleared 510(K)
- K911194IMPEDANCE PHLEBOGRAPH/PHOTOPLETHYSMOGRAPH-DVT-20002Cleared 510(K)
- K904970BODY COMPOSITION ANALYZER2Cleared 510(K)
- K903700IPG-II MODULE2Cleared 510(K)
- K904109BIO-IMPEDANCE ANALYZER2Cleared 510(K)
- K902042EM-SCAN HP-2 PEDIATRIC BODY COMPOSITION ANALYZER2Cleared 510(K)
- K900213PACEMAKER PATIENT ADAPTOR MODULE (PPAM)2Cleared 510(K)
- K900321DYNATRON 330 BODY COMPOSITION ANALYZER2Cleared 510(K)
- K900130MODIFIED SEISMOCARDIOGRAPH2Cleared 510(K)
- K895588PORTABLE AIR PLETHYSMOGRAPH2Cleared 510(K)
- K896034PROCORD MD3500 VASCULAR DIAGNOSTIC SYSTEM2Cleared 510(K)
- K892323SEISMOCARDIOGRAPH - SCG(TM) 1000 SERIES2Cleared 510(K)
- K894892HD-2200 PNEUMO-DOP VASCULAR TESTING SYSTEM2Cleared 510(K)
- K891928HOLTAIN BODY COMPOSITION ANALYSER2Cleared 510(K)
- K893963VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER2Cleared 510(K)
- K890408ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR2Cleared 510(K)
- K883919NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER2Cleared 510(K)
- K881841DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS2Cleared 510(K)
- K884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER2Cleared 510(K)
- K881291AIR PLETHYSMOGRAPH MODEL APG-10002Cleared 510(K)
- K881851VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER2Cleared 510(K)
- K881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER2Cleared 510(K)
- K874938PERIPHERAL VASCULAR LABORATORY ASSISTANT MODEL 1012Cleared 510(K)
- K880926BIOLOGICAL OHM METER, BES 200Z2Cleared 510(K)
- K874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER2Cleared 510(K)
- K871040CONSULTANT BODY COMPOSITION ANALYZER2Cleared 510(K)
- K863833BODY WATCH BODY COMPOSITION ANALYZER MODEL 20102Cleared 510(K)
- K864889OMNI-TRAK2Cleared 510(K)
- K862383MODIFIED MODEL BIA-103 BODY COMPOSITION ANALYZER2Cleared 510(K)
- K8612051990A BIO-RESISTANCE BODY COMPOSITION ANALYZER2Cleared 510(K)
- K862714BILATERAL IMPEDANCE PLETHYSMOGRAPH, BIP(TM)2Cleared 510(K)
- K860749HA-2 HUMAN BODY COMPOSITION ANALYZER2Cleared 510(K)
- K853706BOMED-CDM2Cleared 510(K)
- K852238IPG-3002Cleared 510(K)
- K851415BODY ANALYSIS SYSTEM (DEEMED SE 87/09/18)2Cleared 510(K)
- K852378LIGHT REFLECTION RHEOGRAPHY2Cleared 510(K)
- K833728CARDIAC WALL MOTION DEVICE2Cleared 510(K)
- K833155RAYDEN MEDICAL MINI PULSE VOLUME RECORD2Cleared 510(K)
- K831422BIOFLOW2Cleared 510(K)
- K831421BOMED BIOCON2Cleared 510(K)
- K830292BIOELECTRICAL IMPEDANCE ANALYZER #1012Cleared 510(K)
- K823215CKG 88002Cleared 510(K)
- K822522CUTANEOUS PRESSURE PLETHYSMOGRAPH2Cleared 510(K)
- K822455VASOGRAPH, MODEL MV-22Cleared 510(K)
- K822020CKG 80002Cleared 510(K)
- K820959BLOOD FLOW ANALYZER2Cleared 510(K)
- K811999BO MED BIA2Cleared 510(K)
- K792051CKG CARDIOKYMOGRAPH2Cleared 510(K)
- K781352STRAIN GAUGE PLETHYSMOGRAPH2Cleared 510(K)
- K772092CHEST FLUID MONITOR2Cleared 510(K)
- DSFRecorder, Paper Chart1Product Code
- DSHRecorder, Magnetic Tape, Medical2Product Code
- DXHTransmitters And Receivers, Electrocardiograph, Telephone2Product Code
- DXJDisplay, Cathode-Ray Tube, Medical2Product Code
- DXKEchocardiograph2Product Code
- DXOTransducer, Pressure, Catheter Tip2Product Code
- DXPTransducer, Vessel Occlusion2Product Code
- DXRBallistocardiograph2Product Code
- DYCVectorcardiograph2Product Code
- JOMPlethysmograph, Photoelectric, Pneumatic Or Hydraulic2Product Code
- JONTransducer, Apex Cardiographic2Product Code
- JOOTransducer, Heart Sound2Product Code
- JOPTransducer, Ultrasonic2Product Code
- KRCTester, Electrode, Surface, Electrocardiographic2Product Code
- MLCMonitor, St Segment2Product Code
- MLNElectrode, Electrocardiograph, Multi-Function2Product Code
- MLOElectrocardiograph, Ambulatory, With Analysis Algorithm2Product Code
- MSXSystem, Network And Communication, Physiological Monitors2Product Code
- MUDOximeter, Tissue Saturation2Product Code
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2Product Code
- MWJElectrocardiograph, Ambulatory (Without Analysis)2Product Code
- MXCRecorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)2Product Code
- NMDOximeter, Tissue Saturation, Reprocessed2Product Code
- NQHSensor, Pressure, Aneurysm, Implantable2Product Code
- OCHOximeter, Infrared, Sporting, Aviation2Product Code
- OEYSingle Lead Over-The-Counter Electrocardiograph2Product Code
- QMESoftware For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate2Product Code
- OFILaser Blood Flow Kit2Product Code
- PFYLow Patient Acuity Monitoring System2Product Code
- PLBMultivariate Vital Signs Index2Product Code
- PPWAdjunctive Cardiovascular Status Indicator2Product Code
- QAQAdjunctive Predictive Cardiovascular Indicator2Product Code
- QDAElectrocardiograph Software For Over-The-Counter Use2Product Code
- QDBPhotoplethysmograph Analysis Software For Over-The-Counter Use2Product Code
- QNLMedium-Term Adjunctive Predictive Cardiovascular Indicator2Product Code
- QNVAdjunctive Hemodynamic Indicator With Decision Point2Product Code
- QOKHardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate2Product Code
- QUOAdjunctive Heart Failure Status Indicator2Product Code
- QXZAdjunctive Epicardial Vascular Physiologic Status Indicator2Product Code
- SARAdjunctive Hemodynamic Indicator With Decision Point For Military Use2Product Code
- SDJAdjunctive Cardiac Amyloidosis Status Indicator2Product Code
- SDYLoss Of Pulse Notification Software2Product Code
- 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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AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K081035
- 510(k) Type
- Special
- Applicant
- Osypka Medical, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/30/2008
- Days to Decision
- 49 days
- Submission Type
- Summary