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
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart E—Cardiovascular Surgical DevicesCFR Sub-Part
- BYSOxygenator, Long Term Support Greater Than 6 Hours2Product Code
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass2Product Code
- K234065CDI OneView Monitoring System2Cleared 510(K)
- K202154B-Capta2Cleared 510(K)
- K202557Quantum Workstation 12 Elite2Cleared 510(K)
- K182110CDI Blood Parameter Monitoring System 5502Cleared 510(K)
- K181923Quantum Workstation 12.12Cleared 510(K)
- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas2Cleared 510(K)
- K163657Quantum Workstation2Cleared 510(K)
- K133157TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 62Cleared 510(K)
- K133658CDI BLOOD PARAMETER MONITORING SYSTEM 5002Cleared 510(K)
- K123039CDI BLOOD PARAMETER MONITORING SYSTEM 5002Cleared 510(K)
- K110957M4 MONITOR2Cleared 510(K)
- K103168B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)2Cleared 510(K)
- K091908M3 MONITOR2Cleared 510(K)
- K090147BLOOD MONITORING UNIT, MODEL BMU 402Cleared 510(K)
- K072131M3 MONITOR2Cleared 510(K)
- K071725M2 MONITOR2Cleared 510(K)
- K062468SPECTRUM M2 MONITOR2Cleared 510(K)
- K012743TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T2Cleared 510(K)
- K001388DATA MASTER PERFUSION MONITORING SYSTEM2Cleared 510(K)
- K9807323M CDI QUICK-CELLS WITH HEPARIN TREATMENT2Cleared 510(K)
- K9734723M CDI H/S CUVETTES WITH HEPARON TREATMENT2Cleared 510(K)
- K9729623M CDI BLOOD PARAMETER MONITORING SYSTEM 5002Cleared 510(K)
- K955380IBC QUICK CELL COMPONENT (1/2, 3/8, 1/4)2Cleared 510(K)
- K955379IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)2Cleared 510(K)
- K941922MEDSAT OXYGEN SATURATION SYSTEM2Cleared 510(K)
- K931968CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO2Cleared 510(K)
- K915265CDI(TM) H/S CUVETTE, MODIFICATION2Cleared 510(K)
- K915255CDI(TM) 300, 400 & 100, MODIFICATION2Cleared 510(K)
- K910421SATURATION/HEMATOCRIT MONITOR SYSTEM2Cleared 510(K)
- K903729GOLD GATORS2Cleared 510(K)
- K900682PHANTOM RADIOTRANSLUCENT ECG MONITORING ELECTRODE2Cleared 510(K)
- K900459APPLICARD (EKG)2Cleared 510(K)
- K881006STOCKERT-SHILEY BUBBLE MONITOR 23-23-012Cleared 510(K)
- K874839STAT-SAT2Cleared 510(K)
- K871686GEM-CRIT CHECK2Cleared 510(K)
- K871221CDI(TM) EXTRACORPOREAL BLOOD GAS SYSTEM 3002Cleared 510(K)
- K862953CLASSIC RESTING SILVER-SILVERCHLORIDE ELECTRODE2Cleared 510(K)
- K862069CARDIOMET 4000 GAS MONITORING SYSTEMS2Cleared 510(K)
- K861277CRITICHEM CONTINUOUS BLOOD GAS MONTITOR, CVGM-10002Cleared 510(K)
- K854357GEM-6, WITH COMPONENTS2Cleared 510(K)
- K852124HEMATOCRIT-SATURATION MONITOR HSM-1002Cleared 510(K)
- K843709COBE SATURATION CELL2Cleared 510(K)
- K843538PO 2 LYTRODE2Cleared 510(K)
- K831225GAS-STAT MONITORING SYSTEM2Cleared 510(K)
- K823359OXYGEN CONSUMPTION MONITOR #OCM-01002Cleared 510(K)
- K821159IN-LINE OXYGEN MONITORING SYSTEM2Cleared 510(K)
- K811391OXIMETRIX ACCU SAT CPB2Cleared 510(K)
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass2Product Code
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line2Product Code
- DTNReservoir, Blood, Cardiopulmonary Bypass2Product Code
- DTPDefoamer, Cardiopulmonary Bypass2Product Code
- DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass2Product Code
- DTRHeat-Exchanger, Cardiopulmonary Bypass2Product Code
- DTSSucker, Cardiotomy Return, Cardiopulmonary Bypass2Product Code
- DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass2Product Code
- DTXGas Control Unit, Cardiopulmonary Bypass2Product Code
- DTYSensor, Blood-Gas, In-Line, Cardiopulmonary Bypass2Product Code
- DTZOxygenator, Cardiopulmonary Bypass2Product Code
- DWAControl, Pump Speed, Cardiopulmonary Bypass2Product Code
- DWBPump, Blood, Cardiopulmonary Bypass, Roller Type2Product Code
- DWCController, Temperature, Cardiopulmonary Bypass2Product Code
- DWDSuction Control, Intracardiac, Cardiopulmonary Bypass2Product Code
- DWETubing, Pump, Cardiopulmonary Bypass2Product Code
- DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2Product Code
- DWPDilator, Vessel, Surgical2Product Code
- DWQStripper, Vein, External2Product Code
- DWSInstruments, Surgical, Cardiovascular1Product Code
- DWXStripper, Artery, Intraluminal2Product Code
- DWZDevice, Biopsy, Endomyocardial2Product Code
- DXCClamp, Vascular2Product Code
- DXSGauge, Pressure, Coronary, Cardiopulmonary Bypass2Product Code
- JODFilter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass2Product Code
- JORGenerator, Pulsatile Flow, Cardiopulmonary Bypass3Product Code
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type2Product Code
- KRIAccessory Equipment, Cardiopulmonary Bypass1Product Code
- KRJFilter, Prebypass, Cardiopulmonary Bypass2Product Code
- KRLDetector, Bubble, Cardiopulmonary Bypass2Product Code
- LXNProbe, Test, Heart-Valve1Product Code
- MCWCatheter, Peripheral, Atherectomy2Product Code
- MFYEndothelial Cell Harvesting Kit2Product Code
- MGZValvulotome2Product Code
- MJJCpb Check Valve, Retrograde Flow, In-Line2Product Code
- MJNCatheter, Intravascular Occluding, Temporary2Product Code
- MNJValve, Pressure Relief, Cardiopulmonary Bypass2Product Code
- MWSStabilizer, Heart1Product Code
- NCPCannula, Arterial, Cardiopulmonary Bypass (Cpb), Embolism Protection2Product Code
- NLJStripper, Vein, External, Reprocessed2Product Code
- NMFClamp, Vascular, Reprocessed2Product Code
- NQGStabilizer, Heart, Non-Compression, Reprocessed1Product Code
- OETCardioplegia Solution Administration Kit2Product Code
- OEUCardiopulmonary Bypass Catheter Kit2Product Code
- OFACardiovascular Surgical Instruments Tray1Product Code
- OFGCt Biopsy Tray2Product Code
- PNQApical Closure Device2Product Code
- PYXTemporary Non-Roller Type Right Heart Support Blood Pump3Product Code
- PTNReservoir, Blood, Cardiopulmonary Bypass, Exempt2Product Code
- PZSDual Lumen Ecmo Cannula2Product Code
- QJZExtracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure2Product Code
- QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use2Product Code
- QOHExtracorporeal System For Carbon Dioxide Removal2Product Code
- QHWSingle Lumen Ecmo Cannula2Product Code
- QTFReprocessed Atherectomy Catheter2Product Code
- QWFTubing, Long Term Support Greater Than 6 Hours2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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GEM-6, WITH COMPONENTS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K854357
- 510(k) Type
- Traditional
- Applicant
- DIAMOND ELECTRO-TECH, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/8/1986
- Days to Decision
- 71 days