Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- EZTPacemaker, Bladder3Product Code
- EZWStimulator, Electrical, Implantable, For Incontinence3Product Code
- EZYDevice, Incontinence, Mechanical/Hydraulic3Product Code
- FAHDilator, Urethral, Mechanical2Product Code
- BSSTube, Nasogastric2Product Code
- EXASelector, Size, Ostomy1Product Code
- EXBCollector, Ostomy1Product Code
- EXDIrrigator, Ostomy2Product Code
- EXEProtector, Ostomy1Product Code
- EXFBag, Bile Collecting2Product Code
- EXGBag, Urine Collecting, Ureterostomy1Product Code
- EXHBag, Urinary, Ileostomy1Product Code
- EXIDevice, Paste-On For Incontinence, Sterile1Product Code
- EXJDevice, Incontinence, Urosheath Type, Sterile1Product Code
- EXNSupport, Hernia1Product Code
- EYAStylet, Ureteral1Product Code
- EYBCatheter, Ureteral, Gastro-Urology2Product Code
- EYCCatheter, Upper Urinary Tract2Product Code
- EYIAdaptor, Ureteral Catheter1Product Code
- EYJHolder, Ureteral Catheter1Product Code
- EYKConnector, Ureteral Catheter1Product Code
- EYQGarment, Protective, For Incontinence1Product Code
- EYTSheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile1Product Code
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile1Product Code
- EZBStylet For Catheter, Gastro-Urology1Product Code
- EZCCatheter, Coude2Product Code
- EZDCatheter, Straight2Product Code
- EZKCatheter, Retention Type2Product Code
- EZLCatheter, Retention Type, Balloon2Product Code
- EZMDilator, Esophageal (Metal Olive) Gastro-Urology2Product Code
- EZNDilator, Catheter, Ureteral2Product Code
- EZQPouch, Colostomy1Product Code
- EZRCement, Stomal Appliance, Ostomy1Product Code
- EZSAppliance, Colostomy, Disposable1Product Code
- FAQBag, Urine Collection, Leg, For External Use, Sterile1Product Code
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology2Product Code
- FAXBougie, Urological1Product Code
- FBMCannula And Trocar, Suprapubic, Non-Disposable1Product Code
- FBRUrethrometer1Product Code
- FBWFiliform And Filiform Follower1Product Code
- FBXSound, Urethral, Metal Or Plastic1Product Code
- FCBBag, Hemostatic2Product Code
- FCEEnema Kit1Product Code
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)2Product Code
- FCNUrinary Drainage Collection Kit, For Indwelling Catheter2Product Code
- FEFTube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression2Product Code
- FEGTube, Double Lumen For Intestinal Decompression And/Or Intubation2Product Code
- FEWCatheter, Malecot2Product Code
- FEXInstrument, Catheter, Punch1Product Code
- FEZCatheter And Tube, Suprapubic2Product Code
- FFATube, Drainage, Suprapubic2Product Code
- FFHCollector, Urine, Pediatric, For Indwelling Catheter2Product Code
- FFPDilator, Rectal1Product Code
- FFWString And Tubes, Gastrointestinal, To Locate Internal Bleeding2Product Code
- FGDCatheter, Retention, Barium Enema With Bag2Product Code
- FGEStents, Drains And Dilators For The Biliary Ducts2Product Code
- FGFCatheter, Ureteral Disposable (X-Ray)2Product Code
- FGHCatheter, Double Lumen Female Urethrographic2Product Code
- FGICatheter, Urethrographic, Male2Product Code
- FHAClamp, Penile1Product Code
- FHSDialyzer, Single Coil2Product Code
- FHTSet, Gavage, Infant, Sterile2Product Code
- FIAChair, Dialysis, Unpowered, Without Scales1Product Code
- FIBProtector, Transducer, Dialysis2Product Code
- FIDTubing, Dialysate2Product Code
- FIENeedle, Fistula2Product Code
- FIFSet, Dialysis, Single Needle With Uni-Directional Pump2Product Code
- FIGClamp, Tubing, Blood, Automatic2Product Code
- FIHPump, Infusion Or Syringe, Extra-Luminal2Product Code
- FIISystem, Dialysate Delivery, Sealed2Product Code
- FIJSystem, Dialysate Delivery, Recirculating, Single Pass2Product Code
- FIKSystem, Dialysate Delivery, Recirculating2Product Code
- FILSystem, Dialysate Delivery, Single Pass2Product Code
- FINTank, Holding, Dialysis2Product Code
- FIPSubsystem, Water Purification2Product Code
- K251851DIASAFEplusUS (F00013010)2Cleared 510(K)
- K252181AquaA2Cleared 510(K)
- K250514UPT Series Medical RO Water Treatment System2Cleared 510(K)
- K232953AquaBplus; AquaB LITE2Cleared 510(K)
- K223479AQUAbase nX2Cleared 510(K)
- K231410RenaPure Endotoxin Retentive Filter2Cleared 510(K)
- K223656AmeriWater MediQA Reverse Osmosis System (MSP3HF)2Cleared 510(K)
- K213507AquaA2Cleared 510(K)
- K211035U9000 Plus Ultrafilter2Cleared 510(K)
- K200670EON Portable RO Water Purification System2Cleared 510(K)
- K192398Millenium HX2Cleared 510(K)
- K182367DIASAFEplusUS2Cleared 510(K)
- K171099EON Portable Reverse Osmosis Water Purification System2Cleared 510(K)
- K161304EndoPur Filter2Cleared 510(K)
- K161844Matrix Pre-Treatment Controller2Cleared 510(K)
- K153329MED-TECH Water Systems Inc Exchangeable Carbon Tanks for Dialysis2Cleared 510(K)
- K143617AquaC UNO H2Cleared 510(K)
- K151637UPT Series Medical RO Water System2Cleared 510(K)
- K142285AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz2Cleared 510(K)
- K133149BIOPURE HX2 REVERSE OSMOSIS WATER PURIFICATION SYSTEM2Cleared 510(K)
- K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HF2Cleared 510(K)
- K133783AMERIWATER CENTURION 1500+ REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION2Cleared 510(K)
- K131904MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA2Cleared 510(K)
- K131622MROZ REVERSE OSMOSIS SYSTEM2Cleared 510(K)
- K123282DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS2Cleared 510(K)
- K124059AQUABOSS ECORO DIA I (HT); AQUABOSS ECORO DIA II (HT)2Cleared 510(K)
- K121022AMERIWATER ALARM PANEL - BASE MODEL AND REMOTE, BASE MODEL & REMOTE WITH CONDUCTIVITY, BASE MODEL & REMOTE WITH RESISTIV2Cleared 510(K)
- K112331BIOPURE PORTABLE RO SYSTEMS2Cleared 510(K)
- K111740AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION2Cleared 510(K)
- K110285NEPHROS DSU FILTER, NEPHROS MSU FILTER, NEPHROS SSU FILTER2Cleared 510(K)
- K110578MILLENIUM HX PORTABLE REVERSE OSMOSIS WATER PURIFICATION SYSTEM2Cleared 510(K)
- K102892ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS2Cleared 510(K)
- K093608GAMBRO WATER PURIFICATION UNIT, MODELS WRO 300 AND WRO 300 H2Cleared 510(K)
- K092481HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.22Cleared 510(K)
- K083712WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS2Cleared 510(K)
- K090885NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER2Cleared 510(K)
- K082400DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS2Cleared 510(K)
- K080703BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK2Cleared 510(K)
- K072158AQUA PURE DEIONIZER EXCHANGE SERVICE2Cleared 510(K)
- K071104ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM2Cleared 510(K)
- K061782GAMBRO POSICLEAR2Cleared 510(K)
- K060942WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS2Cleared 510(K)
- K051620MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES2Cleared 510(K)
- K042018ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM2Cleared 510(K)
- K043344DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM2Cleared 510(K)
- K042797WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K041884MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K042089NX STAGE WATER PURIFICATION SYSTEM2Cleared 510(K)
- K031832MEGA PURE CART2Cleared 510(K)
- K041163ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES2Cleared 510(K)
- K033648PERFORMANCE WATER TREATMENT SYSTEM2Cleared 510(K)
- K030348BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE2Cleared 510(K)
- K032004AQUABOSS ECORO DIA 502Cleared 510(K)
- K030652MEDRO SPD2Cleared 510(K)
- K021560MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K022448WATER PURIFICATION SYSTEM2Cleared 510(K)
- K030059PORTABLE RO+ MODEL MROS092Cleared 510(K)
- K022747HYDROPURE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM; HYDROPURE BACK-UP PEDI SYSTEM2Cleared 510(K)
- K011005PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K001755MPW HEMODIALYSIS WATER PURIFICATION SYSTEM2Cleared 510(K)
- K021352DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS2Cleared 510(K)
- K013677MODIFICATION TO: MED-RO REVERSE OSMOSIS SYSTEM2Cleared 510(K)
- K014169WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS2Cleared 510(K)
- K003957DIACLEAR ULTRAFILTER2Cleared 510(K)
- K010592AQUA WATER TREATMENT FOR HEMODIALYSIS2Cleared 510(K)
- K003877MAR COR SERVICES SEMPER PURE RO MACHINE2Cleared 510(K)
- K002045WATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K994292WATER PURIFICATION SYSTEM2Cleared 510(K)
- K994279PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)2Cleared 510(K)
- K001282AIW WATER SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K000249SCHAEFER WATER CENTER HEMODIALYSIS WATER PURIFICATION SYSTEM, MODEL HWPS-1002Cleared 510(K)
- K001811NEU-ION HEMODIALYIS WATER TREATMENT SYSTEM2Cleared 510(K)
- K991495FLUID PROCESS SYSTEMS EXCHANGE CARBON AND DEIONIZATION TANKS FOR USE IN HEMODIALYSIS2Cleared 510(K)
- K993806DIALGUARD ENDOTOXIN REMOVAL DEVICE2Cleared 510(K)
- K993877NELSON WATER SYSTEMS FOR HEMODIALYSIS2Cleared 510(K)
- K993520H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K991519AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K993200MD 420/440/460/470/480/4902Cleared 510(K)
- K992786PURE WATER, INC.'S WATER PURIFICATION SYSTEMS2Cleared 510(K)
- K991916VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K983239WATER PURIFICATION COMPONENTS AND SYSTEMS HEMODIALYSIS2Cleared 510(K)
- K983512WATER TREATMENT SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K983126FIBERFLO HOLLOW FIBER CAPSULE WATER FILTERS2Cleared 510(K)
- K981680ULTRAPURE WATER TREATMENT SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K980182WATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K974899GAMBRO CENTRAL WATER TREATMENT SYSTEM CWP 100 - WRO H2Cleared 510(K)
- K981085GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM2Cleared 510(K)
- K974127HYDRA METER2Cleared 510(K)
- K964539PORTABLE SERIES REVERSE OSMOSIS SYSTEMS 700, 701, 702, 703, 704, 750, MRE-NF, F800-F802, RO SECURA, REVERSE OSMOSIS SYST2Cleared 510(K)
- K945559MAR COR COMPLETE WATER TREATMENT SYSTEM FOR KDNEY DIALYSIS2Cleared 510(K)
- K944493REVERSE OSMOSIS SYSTEM2Cleared 510(K)
- K954928PORTABLE REVERSE OSMOSIS MACHINE2Cleared 510(K)
- K954349FIBERFLO HOLLOW FIBER CARTRIDGE WATER FILTERS2Cleared 510(K)
- K945066AWESMOSIS2Cleared 510(K)
- K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTER2Cleared 510(K)
- K924695ASEPTECH PORTABLE RO+ SYSTEM2Cleared 510(K)
- K952215SERIM HISENSE TEST KIT2Cleared 510(K)
- K920186WATER PURIFICATION SYSTEM FOR HEMODIALYSIS2Cleared 510(K)
- K944385MD400 A/B/C/D/E/F/G2Cleared 510(K)
- K945136RENAGUARD DIALYSATE FILTER2Cleared 510(K)
- K931595REVERSE OSMOSIS EQUIPMENT FOR WATER PURIFICATION2Cleared 510(K)
- K934848MASTER ALERT2Cleared 510(K)
- K915258SERVICE DEIONIZATION SYST/DI TANK EXCHANGE PROGRAM2Cleared 510(K)
- K894300SUBMERSIBLE REVERSE OSMOSIS WATER PURIFICATION SYS2Cleared 510(K)
- K894106DRAKE WILLOCK REVERSE OSMOSIS WATER TREATMENT SYST2Cleared 510(K)
- K871242REVERSE OSMOSIS WATER PURIFICATION SYSTEM2Cleared 510(K)
- K873487HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES2Cleared 510(K)
- K863720HD-100 HEMODIALYSIS SYSTEMS AND ACCESSORIES2Cleared 510(K)
- K842215ASCORBIC ACID2Cleared 510(K)
- K841403HEMO-RO WATER PURIFICATION SYS2Cleared 510(K)
- K822385EXTRAPURE REVERSE OSMOSIS WATER UNIT2Cleared 510(K)
- K811678GAMBRO WATER PURIFICATION MONITOR WRD2Cleared 510(K)
- K802474CMR 300, ROWATER TREATMENT UNIT2Cleared 510(K)
- K800305WATER CONDUCTIVITY MONITOR & CONTROLLER2Cleared 510(K)
- K791086CENTRY 2 SYSTEM #016, 103, 016, 1042Cleared 510(K)
- K771763HEMO-RO2Cleared 510(K)
- FIQCannula, A-V Shunt2Product Code
- FIRPump, Blood, Extra-Luminal2Product Code
- FISFlowmeter, Dialysate2Product Code
- FIWAlarm, Pillow Pressure2Product Code
- FIZMeter, Conductivity, Non-Remote2Product Code
- FJAManometer, Water2Product Code
- FJBDetector, Dialysate Level2Product Code
- FJCDetector, Blood Level2Product Code
- FJDDetector, Leak, Blood2Product Code
- FJFDetector, Air Bubble2Product Code
- FJGDialyzer, Parallel Flow2Product Code
- FJHDialyzer, Disposable2Product Code
- FJIDialyzer, Capillary, Hollow Fiber2Product Code
- FJJDialyzer, Twin Coil2Product Code
- FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2Product Code
- FJMGuard, Shunt2Product Code
- FJNStabilizer, Shunt2Product Code
- FJOPlier, Tube1Product Code
- FJPAdaptor, Y2Product Code
- FJQConnector, Shunt1Product Code
- FJRForceps, Disconnect1Product Code
- FJSCatheter, Peritoneal, Long-Term Indwelling2Product Code
- FJTIntracatheter, Dialysis2Product Code
- FJWRing, Joint1Product Code
- FJXRing, Crimp1Product Code
- FJYPlier, Crimp1Product Code
- FJZDeclotting Tray, Kit (Including Contents)2Product Code
- FKADilator, Vessel2Product Code
- FKBConnector, Blood Tubing, Infusion T2Product Code
- FKCClamp, Cannula1Product Code
- FKDCanister, Coil2Product Code
- FKETie, Dialysis1Product Code
- FKFGun, Tie, Dialysis1Product Code
- FKGTray, Start/Stop (Including Contents), Dialysis1Product Code
- FKHSolution-Test Standard-Conductivity, Dialysis2Product Code
- FKISet, Dialyzer Holder2Product Code
- FKJFilter, Blood, Dialysis2Product Code
- FKLInsert, Pump, Blood2Product Code
- FKMAdaptor, Fistula2Product Code
- FKNAdaptor, Shunt2Product Code
- FKOCatheter, Peritoneal Dialysis, Single Use2Product Code
- FKPSystem, Dialysate Delivery, Single Patient2Product Code
- FKQSystem, Dialysate Delivery, Central Multiple Patient2Product Code
- FKRSubsystem, Proportioning2Product Code
- FKTSystem, Dialysate Delivery, Sorbent Regenerated2Product Code
- FKWTip, Vessel2Product Code
- FKXSystem, Peritoneal, Automatic Delivery2Product Code
- FKYConnector, Tubing, Dialysate2Product Code
- FLAMonitor, Temperature, Dialysis2Product Code
- FLBMeter, Conductivity, Induction, Remote Type2Product Code
- FLCStation, Dialysis Control, Negative Pressure Type2Product Code
- FLDApparatus, Hemoperfusion, Sorbent2Product Code
- FOCBag, Urine Collection, Newborn2Product Code
- FONBag, Drainage, With Adhesive, Ostomy1Product Code
- FPDTube, Feeding2Product Code
- FRQTube, Levine2Product Code
- GBLCatheter, Ureteral, General & Plastic Surgery2Product Code
- GBMCatheter, Urethral2Product Code
- GBTCatheter, Rectal2Product Code
- GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection2Product Code
- GDSBag, Stomal1Product Code
- KDHCatheter (Gastric, Colonic, Etc.), Irrigation And Aspiration2Product Code
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System2Product Code
- KDJSet, Administration, For Peritoneal Dialysis, Disposable2Product Code
- KDKContainer, Transport, Kidney2Product Code
- KDLSet, Perfusion, Kidney, Disposable2Product Code
- KDNSystem, Perfusion, Kidney2Product Code
- KGCTube, Gastro-Enterostomy2Product Code
- KNQDilator, Esophageal2Product Code
- KNRAdapter, A-V Shunt Or Fistula2Product Code
- KNTTubes, Gastrointestinal (And Accessories)2Product Code
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter2Product Code
- KNYAccessories, Catheter, G-U2Product Code
- KNZAccessories, A-V Shunt2Product Code
- KOBCatheter, Suprapubic (And Accessories)2Product Code
- KOCAccessories, Blood Circuit, Hemodialysis2Product Code
- KODCatheter, Urological2Product Code
- KOEDilator, Urethral2Product Code
- KPFSystem, Dialysate Delivery, Semi-Automatic, Peritoneal2Product Code
- KPHCatheter, Rectal For Continent Ileostomy1Product Code
- KPIStimulator, Electrical, Non-Implantable, For Incontinence2Product Code
- KPLColonic Irrigation System2Product Code
- KPMShunt, Peritoneal2Product Code
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)2Product Code
- KPPPeritoneal Dialysate Filter2Product Code
- KQQTubing, Dialysate (And Connector)2Product Code
- KQRDetector, Air Or Foam2Product Code
- KXMSystem Accessories, Extracorporeal2Product Code
- LBWSet, Dialysis, Single Needle (Co-Axial Flow)2Product Code
- LCGIntestinal Splinting Tubes2Product Code
- LFJCatheter, Subclavian2Product Code
- LFKCatheter, Femoral2Product Code
- LIFDialyzer Reprocessing System2Product Code
- LJHSystem, Irrigation, Urological2Product Code
- LKYDevice, External Penile Rigidity2Product Code
- LLBSystem, Blood, Extracorporeal And Accessories2Product Code
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological2Product Code
- LQRDislodger, Stone, Biliary2Product Code
- LRIPh Meter For Dialysis Hydrogen Ion Concentration2Product Code
- MJCCatheter, Urological (Antimicrobial) And Accessories2Product Code
- MLWWarmer, Peritoneal Dialysate2Product Code
- MNGExternal Urethral Occluder, Urinary Incontinence-Control, Female1Product Code
- MNVStrip, Dialysate Ph Indicator2Product Code
- MONSystem, Hemodialysis, Remote Accessories1Product Code
- MPBCatheter, Hemodialysis, Non-Implanted2Product Code
- MQSSystem, Hemodialysis, Access Recirculation Monitoring2Product Code
- MSBSystem And Accessories, Isolated Heart, Transport And Preservation2Product Code
- MSDCatheter, Hemodialysis, Implanted2Product Code
- MSEHemodialyzer, Re-Use, Low Flux2Product Code
- MSFHemodialyzer, Re-Use, High Flux2Product Code
- MSYStrip, Test, Reagent, Residuals For Dialysate, Disinfectant2Product Code
- MSZStrip, Test, Reagent, Residuals For Dialysate2Product Code
- NAMStimulator, Peripheral Nerve, Non-Implanted, For Pelvic Floor Dysfunction2Product Code
- NDSMedia, Culture, Ex Vivo, Tissue And Cell2Product Code
- NFKKit, Repair, Catheter, Hemodialysis2Product Code
- NHVSystem, Water Purification, General Medical Use2Product Code
- NIECatheter, Hemodialysis, Triple Lumen, Non-Implanted2Product Code
- NIFCatheter, Hemodialysis, Triple Lumen, Implanted2Product Code
- NMLCatheter, Biliary, Reprocessed2Product Code
- NNENeedle, Fistula, Reprocessed2Product Code
- NNGSet, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed2Product Code
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile1Product Code
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile1Product Code
- NNYSheath, Corrugated Rubber, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile1Product Code
- NOADevice, Paste-On For Incontinence, Non-Sterile1Product Code
- NOOClamp, Dialysis Arm1Product Code
- NOYAgents, Embolic, For Treatment Of Benign Prostatic Hyperplasia2Product Code
- NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use2Product Code
- NTZStrip, Dialysate, Ph, Bicarbonate, Glucose, Acid, Indicator2Product Code
- NUBColonic Irrigation System, General Well Being3Product Code
- NYUCatheter, Hemodialysis, Implanted, Coated2Product Code
- NWOKit, Catheter, Urinary (Exludes Hiv Testing)2Product Code
- NWPSuprapubic Cystostomy Catheter Kit2Product Code
- NWQKit, Catheter, External, Male (Excludes Hiv Testing)2Product Code
- NWRKit, Catheter, Foley (Excludes Hiv Testing)2Product Code
- NZUCollector, Urine, Powered, Non Indwelling Catheter1Product Code
- ODNUltrafiltration-Controlled Nocturnal Dialysate Delivery System2Product Code
- ODXAutonomous Extracorporeal Blood Leak Detector/Alarm2Product Code
- OHRCatheter Care Tray2Product Code
- ONWHemodialysis System For Home Use2Product Code
- ONYOral Removable Retainer For Weight Management2Product Code
- PBPRectal Insert2Product Code
- PCUPancreatic Stent, Covered, Metallic, Removable2Product Code
- PEHHemodialysis Catheter Luer End Cap2Product Code
- PEVDialysis Administration Kit2Product Code
- PEWImplantable Transprostatic Tissue Retractor System2Product Code
- PFHVenous Window Needle Guide2Product Code
- PIAVibrator For Climax Control Of Premature Ejaculation2Product Code
- PIDEsophageal Dilator Balloon With Or Without Electrode Sensors2Product Code
- PIEEsophageal Dilator With Balloon And Electrode Sensors2Product Code
- PIFGastrointestinal Tubes With Enteral Specific Connectors2Product Code
- QGCSuprapubic Catheter Accessories1Product Code
- PIHUrethral Insert With Pump For Bladder Drainage2Product Code
- PINKidney Perfusion Kit2Product Code
- PIOEnteral Specific Transition Connectors2Product Code
- PJHDynamic Rectal Control System2Product Code
- PKIFully Subcutaneous Implanted Hemodialysis Catheter2Product Code
- PLIGastrointestional Tube Holder2Product Code
- PLQEnzyme Packed Cartridge2Product Code
- PNBBiliary Stent System For Benign Strictures2Product Code
- PNGPeritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling2Product Code
- PNREnteral Syringes With Enteral Specific Connectors2Product Code
- QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss2Product Code
- PPABladder Irrigation Kit2Product Code
- PPBFoley Catheter Kit (Excludes Hiv Testing)2Product Code
- PPCMale External Catheterization Kit (Excludes Hiv Testing)2Product Code
- PPDUniversal Drainage Tray2Product Code
- PPFUrinary Irrigation Kit2Product Code
- PPGUrinary Drainage Collection Kit2Product Code
- PPHSingle Needle With Uni-Directional Pump Kit2Product Code
- PPIHemodialysis Tray (Not A Start/Stop Kit)2Product Code
- PPJPeritoneal Dialysis Administration Kit2Product Code
- PPKPeritoneal Dialysis Tubing Kit2Product Code
- PPLSingle Needle (Co-Axial Flow) Dialysis Kit2Product Code
- PPOMulti-Lumen Hemodialysis Catheterization Kit2Product Code
- PQEOstomy Care Kit1Product Code
- PRMEnteral Administration Kit (Adult & Pediatric)2Product Code
- PROAnti-Regurgitation Blood Tubing Kit2Product Code
- PRPBalloon Gastrostomy Tube Kit2Product Code
- PRQEsophageal Dilator Kit2Product Code
- PRRFeeding Tube Kit2Product Code
- PRSGastric Colonic Catheter Irrigation Kit2Product Code
- PRTGastric Irrigation And Aspiration Kit2Product Code
- PRWGastrointestinal Tube Kit2Product Code
- PRXGastrostomy Guide Wire Placement Kit2Product Code
- PRYGastrostomy Jejunostomy Feeding Tube Kit2Product Code
- PRZGastrostomy Tube Kit2Product Code
- PSALaparoscopic Jejunostomy Kit2Product Code
- PSBNasogastric Feed Tube Kit2Product Code
- PSCNasogastric-Gastrojejunal Kit2Product Code
- PSDLaparoscopic Gastrostomy Kit2Product Code
- PSENeedle Catheter Jejunostomy Kit2Product Code
- PSFNon-Balloon Replacement Gastrostomy System2Product Code
- PSGPercutaneous Endoscopic Gastrostomy Kit2Product Code
- PSHPercutaneous Replacement Gastrostomy Tube Kit2Product Code
- PSJRectal Dilator Kit1Product Code
- PSKReplacement Gastrostomy Feeding Catheter Tray2Product Code
- PSXChlorine Meter2Product Code
- PTKPediatric Esophageal Atresia Anastomosis Device3Product Code
- PTTBiliary Catheter For Irrigation And Contrast Injection, Exempt2Product Code
- PTUCatheter, Peritoneal, Long-Term Indwelling, Exempt2Product Code
- PTVCatheter, Peritoneal Dialysis, Single Use, Exempt2Product Code
- PTWSystem, Peritoneal, Automatic Delivery, Exempt2Product Code
- QAJCutaneous Electrode Stimulator For Urinary Incontinence2Product Code
- QAXHemodialyzer With Expanded Solute Removal Profile2Product Code
- QGDImplanted Mechanical/Hydraulic Urinary Continence Device Surgical Accessories1Product Code
- QGEBiliary Stent, Drain, And Dilator Accessories1Product Code
- QIRPediatric Hemodialysis System2Product Code
- QJNLaparoscopic Accessories, Esophageal Sizing2Product Code
- QKATemporarily-Placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia2Product Code
- QMYComputerized Behavioral Therapy Device For Treating Symptoms2Product Code
- QONImplanted Electrical Device Intended For Treatment Of Fecal Incontinence3Product Code
- QRCNon-Implanted Electrical Stimulation Device For Management Of Premature Ejaculation2Product Code
- SCTFoley Catheters And Accessories With Additional Safety Features2Product Code
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
- Page Type
- Cleared 510(K)
- 510(k) Number
- K981085
- 510(k) Type
- Traditional
- Applicant
- GAMBRO HEALTHCARE
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/18/1998
- Days to Decision
- 54 days
- Submission Type
- Statement