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
- K242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors2Cleared 510(K)
- K221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes2Cleared 510(K)
- K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit2Cleared 510(K)
- K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit2Cleared 510(K)
- K161408Compass Cast and MAP2Cleared 510(K)
- K152472Disposable Pressure Transducer2Cleared 510(K)
- K152980Flo Trac sensor, Volume View sensor2Cleared 510(K)
- K151040Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer2Cleared 510(K)
- K133624COMPASS CT, COMPASS CT PORT2Cleared 510(K)
- K123095MEDLINE BLOOD PRESSURE TRANSDUCER2Cleared 510(K)
- K120624ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)2Cleared 510(K)
- K112203COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST2Cleared 510(K)
- K102033COMBITRANS MONITORING SETS AND ACCESSORIES2Cleared 510(K)
- K103715COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE2Cleared 510(K)
- K101189REAVILLMED PRESSURE MONITORING SYSTEM AND PICC2Cleared 510(K)
- K101518COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE2Cleared 510(K)
- K092644TERUMO PRESSURE ISOLATOR2Cleared 510(K)
- K091408DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K070710ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM2Cleared 510(K)
- K062342TRUEPULSE DISPOSABLE INVASIVE BLOOD PRESSURE MONITORING KIT2Cleared 510(K)
- K061573TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KIT2Cleared 510(K)
- K052828DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT)2Cleared 510(K)
- K043065VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P2Cleared 510(K)
- K983372BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP2Cleared 510(K)
- K981747BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX2Cleared 510(K)
- K981745BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX2Cleared 510(K)
- K961404MX960 REUSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K951722PERCEPTOR COMPENSATOR MORSE MANIFOLD2Cleared 510(K)
- K951129NOVATRANS II2Cleared 510(K)
- K930888WRISTRECORDER PLUS CARDIAC EVENT RECORDING SYSTEM2Cleared 510(K)
- K921343COBE PATIENT MONITORING PRODUCTS2Cleared 510(K)
- K920977MERITRANS(TM) DISPOSABLE TRANSDUCER2Cleared 510(K)
- K921898TAD MODEL #96552Cleared 510(K)
- K910764THE PERCEPTOR(TM) STAND ALONE TRANSDUCER2Cleared 510(K)
- K904777SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS2Cleared 510(K)
- K904601ADVANCE DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K902472MORSE DT MANIFOLD2Cleared 510(K)
- K902453OSCILLOMETRIC PULSE DETECTION DEVICE2Cleared 510(K)
- K900551MATRX DISPOSABLE NON-INVASIVE GELLED PACING ELEC.2Cleared 510(K)
- K884235COMBITRANS DISPOSABLE PRESSURE TRANSDUCER KIT2Cleared 510(K)
- K885296MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F2Cleared 510(K)
- K884919DISPOSABLE DOME STOCK #D-3002Cleared 510(K)
- K881297BARO-GRAF 242Cleared 510(K)
- K883095MX860, REUSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K882118MODEL 700 PATIENT MONITOR2Cleared 510(K)
- K873168SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS2Cleared 510(K)
- K872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F302Cleared 510(K)
- K871371DIGITAL SPHYGMOMANOMETER2Cleared 510(K)
- K870356TATCH-IT2Cleared 510(K)
- K870301MX900-DPT, DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K864090SHELF LIFE CHANGE OF STERILE DEVICES2Cleared 510(K)
- K862344GOULD XCALIBER2Cleared 510(K)
- K860681DISPOSABLE FLUSH DEVICE2Cleared 510(K)
- K854596TDK ECG ELECTRODE MEL-08-09 & -112Cleared 510(K)
- K853996DISPOSABLE PRESSURE TRANSDUCER SYSTEM STERILE2Cleared 510(K)
- K855145MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR2Cleared 510(K)
- K854505CARDIMAX FX-406U2Cleared 510(K)
- K852652OMNIGRAPH 4000(ELECTROCARDIOGRAPH)2Cleared 510(K)
- K841960CARDIO METRICS INVASIVE PRESSURE MONIT2Cleared 510(K)
- K851486GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX2Cleared 510(K)
- K841811BENTLEY-TRANTEC DISPOS. DOMES D-260-2Cleared 510(K)
- K851989DOME, DISPOSABLE, STERILE2Cleared 510(K)
- K851988ADMINISTRATION SET2Cleared 510(K)
- K851987FLUSH DEVICE, AUTOMATIC2Cleared 510(K)
- K851888APM DISPOS. BLOOD PRESSURE TRANSDUCER2Cleared 510(K)
- K850898MEDI-TRACE DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K843273DISPOS. PRESSURE KIT 1295K SERIES2Cleared 510(K)
- K843580MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO2Cleared 510(K)
- K842352PRESSURE MONITORING KIT2Cleared 510(K)
- K841788UTAH DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K841613PRESSURE TRANSDUCER DOME 1295C2Cleared 510(K)
- K833171MONITORING KIT2Cleared 510(K)
- K833170FLUSH DEVICE2Cleared 510(K)
- K841968DESERET DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K840023TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC2Cleared 510(K)
- K840121PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C2Cleared 510(K)
- K840274CARDIOFAX ECG 65432Cleared 510(K)
- K832897MODEL TTPM TIME TEMP. PRESSURE MONITOR2Cleared 510(K)
- K833792TRANTECSILICONE QUARTZ DISP. TRANSD2Cleared 510(K)
- K832907INVASIVE MONITORING KITS2Cleared 510(K)
- K833271NAMIC CONTINUOUS FLUSH DEVICE2Cleared 510(K)
- K832657DISPOSABLE MANIFOLD SET2Cleared 510(K)
- K833095TRANSDUCER DOME SD1052Cleared 510(K)
- K833096TRANSDUCER DOME DS1062Cleared 510(K)
- K833094TRANSDUCER DOME SD1042Cleared 510(K)
- K831867PRESSURE MONITORING IV BOTTLE CAP2Cleared 510(K)
- K831506DISP. TRANSDUCER W/MONITORING KIT TRANS2Cleared 510(K)
- K831698DISPOSABLE PRESSURE TRANSDUCER#140041952Cleared 510(K)
- K831348FLUID ADMIN. SET AFS-1C2Cleared 510(K)
- K830210DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K823334PHYSIOLOGICAL PRESS. TRANSDUCER PCM36302Cleared 510(K)
- K830093USCI ELECTRONIC MANOMETER2Cleared 510(K)
- K823286MODELS DPT 1000/DPT 1000NS2Cleared 510(K)
- K822507DISPOSABLE TRANSDUCER & ACCESSORIES2Cleared 510(K)
- K821894DISPOSABLE TRANSDUCER DOMES & KITS2Cleared 510(K)
- K821416DISPOSABLE BLOOD PRESSURE TRANSDUCER2Cleared 510(K)
- K820459VIRAGARD/VIRASHIELD2Cleared 510(K)
- K821450PRESSURE TUBING-ADULT & PEDIATRIC2Cleared 510(K)
- K820579FLEX-E1 ECG ELECTRODE2Cleared 510(K)
- K820676TOUCH FLUSH W/Y TRANSDUCER CONNECTOR2Cleared 510(K)
- K820677TOUCH FLUSH CONTINUOUS FAST/FLUSH2Cleared 510(K)
- K820457MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS2Cleared 510(K)
- K820355DISPOSABLE DIAPHRAGM DOMES2Cleared 510(K)
- K820342PHYSIOLOGICAL PRESSURE TRANSDUCER #9002Cleared 510(K)
- K820202CONTINUOUS FLUSH DEVICE/FDI2Cleared 510(K)
- K820201DISPOS. MONITORING SYS/LI ET AL2Cleared 510(K)
- K820186BARD CARDIOPULMONARY MONITORING LINES2Cleared 510(K)
- K820046ANESTHESIOLOGY DEVICES2Cleared 510(K)
- K813266NIHON KOHDEN ELECTROCARDIOGRAPH2Cleared 510(K)
- K813549CONTINUOUS FLUSH DEVICE2Cleared 510(K)
- K813464DISPOSABLE TRANSDUCER2Cleared 510(K)
- K813502NARCO TELECARE ISOFLO PRESSURE MONITOR2Cleared 510(K)
- K813267DISPOSABLE DIAPHRAGM DOMES2Cleared 510(K)
- K813137CORREC TORR TM2Cleared 510(K)
- K813053DISPOSABLE BLOOD PRESSURE TRANSDUCER DOM2Cleared 510(K)
- K812884NARCO TELECARE PRESSURE TRANSDUCER DOME2Cleared 510(K)
- K812883TELECARE ISOTEC PRESSURE TRANSDUCER DOME2Cleared 510(K)
- K812758PHYSIOLOGICAL PRESSURE TRANSDUCER2Cleared 510(K)
- K812530TRANSDUCER DOME2Cleared 510(K)
- K811980ELECTRONIC BLOOD PRESSURE TRANSDUCER MAN2Cleared 510(K)
- K811538MODELS TA 1017 & 1017T GRITIFLO DISPOS2Cleared 510(K)
- K810735DISPOSABLE, STERILE TRANSDUCER DOMES2Cleared 510(K)
- K810637COBE DISPOSABLE PRESSURE TRANSDUCER2Cleared 510(K)
- K810661CATHDAMP2Cleared 510(K)
- K810431NARCO TLECARE MINIATURE PRESSURE DOME2Cleared 510(K)
- K810009DISPOSABLE DIAPHRAGM DOME2Cleared 510(K)
- K803096NARCO TELECARE TRANSDUCER DOME #700-40002Cleared 510(K)
- K802179CARDIOSCOPE J2002Cleared 510(K)
- K802069DISP. TRANSDUCER DOMES TD200 & TD3002Cleared 510(K)
- K801985BIO-MED CORP. DISP. NON-STERILE TRANSDU2Cleared 510(K)
- K801239STERILE, DISP DOME, INDIVID. PKG.2Cleared 510(K)
- K801138MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.2Cleared 510(K)
- K801136D300 DOME2Cleared 510(K)
- K801048ACCUDYNAMIC2Cleared 510(K)
- K800706MEDI-TRACE DISPOSABLE DOMES/MONITORING2Cleared 510(K)
- K800705MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO2Cleared 510(K)
- K792020AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER2Cleared 510(K)
- K792073MODEL 1979 BLOOD PRESSUROMETER R CHARTER2Cleared 510(K)
- K791636ACCUNAMIC2Cleared 510(K)
- K790407MICROTEC BACTERIAL FILTER2Cleared 510(K)
- K781680MONITORING, PRESSURE KIT2Cleared 510(K)
- K780797TRANSDUCER, PRESSURE, OPTION, H-P, P23ID2Cleared 510(K)
- K780477PHYSIOLOGICAL PRESSURE TRANSDUCER2Cleared 510(K)
- K780127DINAMAP MODEL 8502Cleared 510(K)
- K780128BLOOD PRESSURE MONITOR, ARTERIAL2Cleared 510(K)
- K771668DISP. FLUID ISOLATOR & PRESS. RELIEF2Cleared 510(K)
- K771361PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A2Cleared 510(K)
- K761325MODEL DA-53 PRESSURE GUAGE ISOLATOR2Cleared 510(K)
- 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
- 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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GOULD XCALIBER
- Page Type
- Cleared 510(K)
- 510(k) Number
- K862344
- 510(k) Type
- Traditional
- Applicant
- BIO-TEK INSTRUMENTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/6/1986
- Days to Decision
- 47 days