Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- FLGCleaner, Ultrasonic, Medical Instrument1Product Code
- FLHWasher Of Body Waste Receptacles1Product Code
- FLICabinet, Ethylene-Oxide Gas Aerator2Product Code
- BRTRestraint, Patient, Conductive1Product Code
- BYYTube, Aspirating, Flexible, Connecting2Product Code
- BYZTrap, Sterile Specimen2Product Code
- CBCBottle, Collection And Trap, Breathing System (Uncalibrated)2Product Code
- CBDBottle, Collection, Breathing System (Calibrated)2Product Code
- FLESterilizer, Steam2Product Code
- FLFSterilizer, Ethylene-Oxide Gas2Product Code
- FMADepressor, Tongue, Non-Surgical1Product Code
- FMCPatient Examination Glove1Product Code
- FMEGown, Examination1Product Code
- FMLChair, Blood Donor1Product Code
- FMPProtector, Skin Pressure1Product Code
- FMQRestraint, Protective1Product Code
- FMRDevice, Transfer, Patient, Manual1Product Code
- FMWCover, Mattress (Medical Purposes)1Product Code
- FNPUrinal1Product Code
- FNSRing Cutter1Product Code
- FNYBasin, Emesis1Product Code
- FOABoard, Cardiopulmonary1Product Code
- FOBBedpan1Product Code
- FOXStand, Infusion1Product Code
- FPFBottle, Hot/Cold Water1Product Code
- FPOStretcher, Wheeled2Product Code
- FPPStretcher, Hand-Carried1Product Code
- FPSBoard, Bed1Product Code
- FRAPurifier, Air, Ultraviolet, Medical2Product Code
- FRGWrap, Sterilization2Product Code
- FRJChair, Geriatric1Product Code
- FRKChair, Examination And Treatment1Product Code
- FRZDevice, Patient Transfer, Powered2Product Code
- GAZTubing, Noninvasive2Product Code
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered2Product Code
- JOKScissors, Medical, Disposable1Product Code
- JOLCatheter And Tip, Suction2Product Code
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories2Product Code
- KDPRegulator, Vacuum2Product Code
- KDQBottle, Collection, Vacuum2Product Code
- KIACover, Cast1Product Code
- KMEBedding, Disposable, Medical1Product Code
- KMGPurifier, Water, Ultraviolet, Medical2Product Code
- KMHSterilizer, Dry Heat2Product Code
- KMJLubricant, Patient1Product Code
- KMNChair And Table, Medical1Product Code
- KXFApplicator, Absorbent Tipped, Non-Sterile1Product Code
- KXGApplicator, Absorbent Tipped, Sterile1Product Code
- KYRBag, Ice1Product Code
- KYSInsoles, Medical1Product Code
- KYTLight, Examination, Medical, Battery Powered1Product Code
- KYWContainer, Liquid Medication, Graduated1Product Code
- KYXDispenser, Liquid Medication1Product Code
- KYZSyringe, Irrigating (Non Dental)1Product Code
- KZADevice, Vein Location, Liquid Crystal1Product Code
- KZFDevice, Medical Examination, Ac Powered1Product Code
- KZHIntroducer, Syringe Needle2Product Code
- LBJDevice, Vein Stabilization1Product Code
- LDSDevice, Pasteurization, Hot Water2Product Code
- LRJDisinfectant, Medical Devices1Product Code
- K992661CONTROL III ELITE1Cleared 510(K)
- K991509PRO-PORTION CLEANER/DISINFECTANT1Cleared 510(K)
- K984485MICROSTAT 21Cleared 510(K)
- K983947AMERSE 21Cleared 510(K)
- K983869DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH1Cleared 510(K)
- K983585LOW PH PHENOLIC 2561Cleared 510(K)
- K982985CITREX HOSPITAL SPRAY DISINFECTANT1Cleared 510(K)
- K981023KLEENASEPTIC1Cleared 510(K)
- K980369T.B.Q. RTU1Cleared 510(K)
- K974304GERMICIDAL CLOTH1Cleared 510(K)
- K961044NOVIGUARD QUICK DRY1Cleared 510(K)
- K970825BLUE CHIP GERMICIDAL CLEANER & DEODORANT1Cleared 510(K)
- K964376CIDE-SWIPES P-100B & CIDE-SWIPES C-100A1Cleared 510(K)
- K964828VIREX II 128 GERMICIDAL CLEANER AND DEODORANT1Cleared 510(K)
- K964835COVERAGE SPRAY HBV1Cleared 510(K)
- K964749COVERAGE HBV1Cleared 510(K)
- K964613VIREX II 256 GERMICIDAL CLEANER AND DEODORANT1Cleared 510(K)
- K964610TRIAD II DISINFECTANT CLEANER AND DEODORANT1Cleared 510(K)
- K964535VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT1Cleared 510(K)
- K963353LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46)1Cleared 510(K)
- K962739T.B.Q.1Cleared 510(K)
- K960836DMS-90001Cleared 510(K)
- K960580BEAUCOUP GENERAL PURPOSE DISINFECTANT1Cleared 510(K)
- K960583MATAR GENERAL PURPOSE DISINFECTANT1Cleared 510(K)
- K960582ASCEND GENERAL PURPOSE DISINFECTANT1Cleared 510(K)
- K955850PRO-TECH1Cleared 510(K)
- K923693KLORMAN1Cleared 510(K)
- K934150BIOCIDE CLEANER/DISINFECTANT1Cleared 510(K)
- K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT1Cleared 510(K)
- K952929LD GENERAL PURPOSE DISINFECTANT1Cleared 510(K)
- K954292Q5. 5-5.5NPB-2.5HW1Cleared 510(K)
- K952405CITRACE HOSPITAL GERMICIDAL DEODORIZER1Cleared 510(K)
- K952336DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH1Cleared 510(K)
- K951020TRI-CEN GERMICIDAL DETERGENT1Cleared 510(K)
- K953011FORMULATION HWS-64 EPA REG. NO. 47371-1311Cleared 510(K)
- K953009FORMULATION HWS-128 EPA REG. NO. 47371-1301Cleared 510(K)
- K953010FORMULATION HWS-256 EPA REG. NO. 47371-1291Cleared 510(K)
- K951512PRECISE HOSPITAL FOAM CLEANER DISINFECTANT1Cleared 510(K)
- K952302AMUCHINA1Cleared 510(K)
- K951162PHENO-CEN GERMICIDAL DETERGENT1Cleared 510(K)
- K941439RENALIN COLD STERILANT1Cleared 510(K)
- K951983IMNI-II1Cleared 510(K)
- K951317PHENO-CEN SPRAY DISINFECTANT DEODORANT1Cleared 510(K)
- K951342Q4.5-5.0PB-4.51Cleared 510(K)
- K951123CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER1Cleared 510(K)
- K940382LYSOL I.C. BRAND DISINFECTANT1Cleared 510(K)
- K946078HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT1Cleared 510(K)
- K945227OCIDE HOSPITAL CLEANER-DISINFECTANT1Cleared 510(K)
- K950553COLDCIDE-21Cleared 510(K)
- K950516COLDCIDE-101Cleared 510(K)
- K950324MULTI-WASH1Cleared 510(K)
- K944179CONTROL III DISINFECTANT GERMICIDE1Cleared 510(K)
- K944037DIACIDE HD DISINFECTING SOLUTION1Cleared 510(K)
- K940383LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK1Cleared 510(K)
- K940400LYSOL I.C. BRAND DISINFECTANT SPRAY1Cleared 510(K)
- K940381LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT1Cleared 510(K)
- K931477AMERSE1Cleared 510(K)
- K931816VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM1Cleared 510(K)
- K931342LPH1Cleared 510(K)
- K931573VESPHENE II1Cleared 510(K)
- K932277LONZA FORMULATION R-821Cleared 510(K)
- K932502LONZA FORMULATION R-821Cleared 510(K)
- K924434CIDEX ACTIVATED DIALDEHYDE SOLUTION1Cleared 510(K)
- K923744CIDEX PLUS 28 DAY SOLUTION1Cleared 510(K)
- K926013SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI1Cleared 510(K)
- K922262SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT1Cleared 510(K)
- K904581SPORICIDIN BRAND DISINFECTANT SOLUTION1Cleared 510(K)
- K904580SPORICIDIN BRAND DISINFECTANT SPRAY1Cleared 510(K)
- K904579SPORICIDIN BRAND DISINFECTANT TOWELETTES1Cleared 510(K)
- K882564RENALIN COLD STERILANT1Cleared 510(K)
- K870759CLEANING SOLUTION, CATALOG NO. 82031Cleared 510(K)
- K870276HEATED INSTRUMENT BATH1Cleared 510(K)
- LYYLatex Patient Examination Glove1Product Code
- LYZVinyl Patient Examination Glove1Product Code
- LZAPolymer Patient Examination Glove1Product Code
- LZBFinger Cot1Product Code
- LZCPatient Examination Glove, Specialty1Product Code
- MDZCleaners, Medical Devices2Product Code
- MECDisinfector, Medical Devices2Product Code
- MEDSterilant, Medical Devices2Product Code
- MKBDevice, Germicidal, Ultraviolet2Product Code
- MLRSterilizer, Chemical2Product Code
- MMSLubricant, Vaginal, Patient1Product Code
- MTVSharps Needle Destruction Device2Product Code
- NRVImplantable Radio Frequency Transponder System2Product Code
- NZDStretcher, Patient Restraint1Product Code
- NZHMedication Management System, Remote2Product Code
- NZJRespirator, N95, For Use By The General Public In Public Health Medical Emergencies2Product Code
- OHYPill Crusher/Cutter1Product Code
- OIGPowder-Free Guayle Rubber Examination Glove1Product Code
- PEQAccessories To Examination Light1Product Code
- OPCPowder-Free Polychloroprene Patient Examination Glove1Product Code
- OPHRadiation Attenuating Medical Glove1Product Code
- OPIAntimicrobial Medical Glove1Product Code
- OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs1Product Code
- ORWN95 Respirator With Antimicrobial/Antiviral Agent For Use By The General Public In Public Health Medical Emergencies2Product Code
- OSZAntimicrobial Keyboard2Product Code
- OUGMedical Device Data System1Product Code
- OVYLiquid Chemical Processing System2Product Code
- OYSPatient Bed With Canopy/Restraints1Product Code
- PADChest Drainage Kit2Product Code
- PECSterilizer Automated Loading System2Product Code
- PJJTwo Or More Sterilant Sterilizer2Product Code
- PWMAdmission Kit (Patient Utensil)1Product Code
- PYQRfid Chip For Dental Appliance2Product Code
- PWPBlood Borne Pathogen Response Kit1Product Code
- PWSChemotherapy Administration Kit1Product Code
- PWTChemotherapy Spill Clean-Up Kit1Product Code
- PWUClean-Up Kit1Product Code
- PWVDelivery Room Apparel Kit1Product Code
- PWZMid-Stream Collection Kit1Product Code
- PXAOral Administration Set1Product Code
- PXCPersonal Protection Kit1Product Code
- PXDPrep Kit1Product Code
- PXFSitz Bath Kit1Product Code
- PXGSpill Kit1Product Code
- PXMVomitus Clean-Up Kit1Product Code
- QDOFentanyl And Other Opioid Protection Glove1Product Code
- QTVMattress And Bed Deck Cover (Medical Purposes)1Product Code
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- 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
IMNI-II
- Page Type
- Cleared 510(K)
- 510(k) Number
- K951983
- 510(k) Type
- Traditional
- Applicant
- COTTRELL, LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/20/1995
- Days to Decision
- 54 days
- Submission Type
- Summary