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
- DSFRecorder, Paper Chart1Product Code
- DSHRecorder, Magnetic Tape, Medical2Product Code
- DXHTransmitters And Receivers, Electrocardiograph, Telephone2Product Code
- DXJDisplay, Cathode-Ray Tube, Medical2Product Code
- DXKEchocardiograph2Product Code
- K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter2Cleared 510(K)
- K160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)2Cleared 510(K)
- K031148IN-VISION IMAGING SYSTEM2Cleared 510(K)
- K9348879750 ATHENA ETHERNET OPTION2Cleared 510(K)
- K913209ACCESSORY TO GENESIS III (GCFM)2Cleared 510(K)
- K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 546002Cleared 510(K)
- K904832MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST2Cleared 510(K)
- K904975VISTA VIEWING STATION2Cleared 510(K)
- K904978SOFTWARE PROGRAM USED W/PRISM PRODUCTS2Cleared 510(K)
- K904977CINE/VIEW PLUS - CARDIOLOGY WORKSTATION2Cleared 510(K)
- K904976CINE'VIEW - STRESS ECHO & IMAGE REVIEW2Cleared 510(K)
- K910029PATIENT CARE MANAGEMENT SYSTEM MODIFICATION2Cleared 510(K)
- K903839INTERSPEC APOGEE2Cleared 510(K)
- K903710WASHINGTON CARDIAC MONITOR2Cleared 510(K)
- K901592MODEL MD-5 DOPPLER2Cleared 510(K)
- K903414TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN2Cleared 510(K)
- K901658ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND2Cleared 510(K)
- K901657ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND2Cleared 510(K)
- K900350LEOCOR CORFLO(TM) PUMP2Cleared 510(K)
- K901562CVIS INSIGHT IMAGING CATHETER2Cleared 510(K)
- K900002DOPPLER OPTION FOR PLATINUM2Cleared 510(K)
- K895326EUB-1652Cleared 510(K)
- K896543ULTRAMARK 7 ULTRASOUND SYSTEM2Cleared 510(K)
- K894370GENESIS III, (MOD. 7003/7004)2Cleared 510(K)
- K894632MODEL SSH-140A ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K885349SONOMICROMETER, ULTRASONIC DIMENSION SYSTEM, CARD.2Cleared 510(K)
- K883845RESUBMITTED AI 5200 ULTRASOUND TRANSDUCER2Cleared 510(K)
- K883888CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST.2Cleared 510(K)
- K880217SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.2Cleared 510(K)
- K870878EUB-305 DIAGNOSTIC ULTRASOUND DEVICE2Cleared 510(K)
- K871555RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.2Cleared 510(K)
- K875272SONOLINE CF2Cleared 510(K)
- K873762SERIES 77000 ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K873032GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN2Cleared 510(K)
- K871697GENESIS II2Cleared 510(K)
- K863387MULTIPLE2Cleared 510(K)
- K871400SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING2Cleared 510(K)
- K863589MODEL 600 VASCULAR DUPLEX IMAGER2Cleared 510(K)
- K864657ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM2Cleared 510(K)
- K862859EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND2Cleared 510(K)
- K863965KENZ-ECG 1022Cleared 510(K)
- K861710MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY2Cleared 510(K)
- K855229CFM-10 VINGMED COLOR FLOW MAPPING SYSTEM2Cleared 510(K)
- K853115SONOLAYER S, SSH-60A/SDS-60A2Cleared 510(K)
- K852739SONOLINE SX ULTRASOUND SCANNER2Cleared 510(K)
- K854606SONOLAYER S, SSH-65A2Cleared 510(K)
- K853769IRREGULAR CURVE TRACING REVISITION & DOPPLER2Cleared 510(K)
- K851901750 SD ULTRASOUND SCANNER(MODIFICATION)2Cleared 510(K)
- K852543KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM2Cleared 510(K)
- K851426ACCUCOM CARDIAC OUTPUT MONITOR2Cleared 510(K)
- K844896DEL MAR AVIONICS 8300 SECTOR IMAGER SYS2Cleared 510(K)
- K843643COLOR DOPPLER 8802Cleared 510(K)
- K841263CARDIOSCAN - TM BEING APPLIED FOR2Cleared 510(K)
- K822425M-MODE ANALYSIS SYSTEM2Cleared 510(K)
- K822236FRANKLIN QUANTIC 12002Cleared 510(K)
- K820145ALLTEK BROMPTON ENCODER2Cleared 510(K)
- K813002MAVIS C2Cleared 510(K)
- K812646SKI 50002Cleared 510(K)
- K812209ULTRA COM2Cleared 510(K)
- K812184ANGIOSCAN SPECTRUM ANALYZER2Cleared 510(K)
- K811595SP-100-B SMALL PARTS SCANNER SYSTEM2Cleared 510(K)
- K811556DC-1 CARDIAC IMAGING MODULE2Cleared 510(K)
- K802917MARK III ULTRASONIC SCANNING SYSTEM2Cleared 510(K)
- K802529PFIZONIC 100 ULTRASOUND SCANNER2Cleared 510(K)
- K802670CONTIUOUS WAVE DOPPLER ULTRASOUND2Cleared 510(K)
- K802030U.I. OCTOSON2Cleared 510(K)
- K800850HIGH STOY SMALL PARTS SCANNER #SP-100B2Cleared 510(K)
- K800805LINEAR ARRAY SCANNER2Cleared 510(K)
- K800653SINVISION LINEAR ARRAY REAL TIME2Cleared 510(K)
- K800553ULTRA IMAGER2Cleared 510(K)
- K801224CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM2Cleared 510(K)
- K792373IPCO M-101 ECHOCARDIOGRAPH (IPCO ULTRA-2Cleared 510(K)
- K792540SONACOLOR 60002Cleared 510(K)
- K780332CATHODE RAY TUBE DISPLAY MODEL 1340A2Cleared 510(K)
- K771292HIGH-SPEED SECTOR SCANNING SSL-52H2Cleared 510(K)
- K770755ECHOCARDIOGRAPHY SYS., MODEL 38302Cleared 510(K)
- K770756ECHOCARDIOGRAPHY SYS., MODEL 38602Cleared 510(K)
- K770073PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.2Cleared 510(K)
- 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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SKI 5000
- Page Type
- Cleared 510(K)
- 510(k) Number
- K812646
- 510(k) Type
- Traditional
- Applicant
- SMITH KLINE DIAGNOSTICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/16/1981
- Days to Decision
- 60 days