Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- HKXTonometer, Ac-Powered2Product Code
- K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA2Cleared 510(K)
- K223739VS Tabletop Tonometer2Cleared 510(K)
- K190382Intraocular Pressure Tonometer EASYTON2Cleared 510(K)
- K181260MiiS Horus Scope DPT 1002Cleared 510(K)
- K181143Keeler TonoCare Tonometer2Cleared 510(K)
- K180820Tono Vue Non-Contact Tonometer2Cleared 510(K)
- K162067VX130 Ophthalmic Diagnostic Device2Cleared 510(K)
- K143086VX120 Ophthalmic Diagnostic Device2Cleared 510(K)
- K113066CORVIS ST2Cleared 510(K)
- K111710FULL AUTO TONOMETER MODEL TX-202Cleared 510(K)
- K093298PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-20002Cleared 510(K)
- K083377ACCUPEN2Cleared 510(K)
- K073087NON-CONTACT TONOMETER, MODEL FT-10002Cleared 510(K)
- K081756OCULAR RESPONSE ANALYZER2Cleared 510(K)
- K053444KOWA KT-8002Cleared 510(K)
- K060780TONOMETER DIATON2Cleared 510(K)
- K042099TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)2Cleared 510(K)
- K032799NON-CONTACT TONOMETERS, OCULAR RESPONSE ANALYZER2Cleared 510(K)
- K031733NON-CONTACT TONOMETER, MODEL NT-40002Cleared 510(K)
- K023676APPLANATION TONOMETER2Cleared 510(K)
- K023816CANON FULL AUTO TONOMETER TX-F2Cleared 510(K)
- K021937TGDC-01 PRA2Cleared 510(K)
- K013805KOWA AUTOMATED TONOMETER KT-5002Cleared 510(K)
- K013259PORTABLE NON-CONTACT TONOMETER, MODEL PT1002Cleared 510(K)
- K010998LANGHAM OCULAR BLOOD FLOW (OBF) TONOGRAPH/TONOMETER MODEL 2012Cleared 510(K)
- K002395MODEL 30 CLASSIC PNEUMATONOMETER2Cleared 510(K)
- K002510SMARTLENS2Cleared 510(K)
- K990869LEICA AT5502Cleared 510(K)
- K990257KEELER PULSAIR 3000 NON CONTACT TONOMETER2Cleared 510(K)
- K963079CANON TX-10 TONOMETER2Cleared 510(K)
- K953031ZEIMER SELF TONOMETER2Cleared 510(K)
- K945972DIGITAL AVERAGING TONOMETER2Cleared 510(K)
- K943939NON-CONTACT TONOMETER T-22Cleared 510(K)
- K941865XPERT NCT2Cleared 510(K)
- K921443TIP & MEMBRANE ASSEMBLY2Cleared 510(K)
- K924777BURTON APPLANATION TONOMETER - MODEL T850 & T10002Cleared 510(K)
- K921617CYLINDER OF GAS, CAN OF GAS (CC12F2)2Cleared 510(K)
- K913189NIDEK MODEL NT-10002Cleared 510(K)
- K911721KEELER PULSAIR NON CONTACT TONOMETER, MODIFICATION2Cleared 510(K)
- K895575BIO-RAD MODULAR AIR COMPRESSOR2Cleared 510(K)
- K884012MMAC II TONOMETER2Cleared 510(K)
- K873917TONOMETER TAPES2Cleared 510(K)
- K873422OBF MODEL 115 COMPUTER TONOMETER SYSTEM2Cleared 510(K)
- K871935T P C (TONOMETER PROBE COVER)2Cleared 510(K)
- K871335TOPCON COMPUTERIZED TONOMETER CT-102Cleared 510(K)
- K870750KEELER PULSAIR NON CONTACT TONOMETER2Cleared 510(K)
- K870121DIGILAB MICRO ONE APPLANATION TONOMETER2Cleared 510(K)
- K864959OBF MODEL 112 VACUUM CUP SYSTEM2Cleared 510(K)
- K863235SURGICAL IOP MONITOR2Cleared 510(K)
- K863217DIGILAB MODULAR ONE-APPLANATION TONOMETER2Cleared 510(K)
- K863200COMPUTON(R)2Cleared 510(K)
- K843354EPISCLERAL VENOUS PRESSURE2Cleared 510(K)
- K841762WOODLYN APPLANATION TONOMETER2Cleared 510(K)
- K840836CAT 1002Cleared 510(K)
- K833494CLERZ LUBRICATING/REWETTING SOLUTION2Cleared 510(K)
- K820751GLAUKON2Cleared 510(K)
- K802419AO NON-CONTACT II TONOMETER2Cleared 510(K)
- K801518SPAN-AID BRIDGING PILLOW SYSTEM2Cleared 510(K)
- HKYTonometer, Manual2Product Code
- HKZSterilizer, Tonometer1Product Code
- HLACalibrator, Tonometer2Product Code
- HLCInstrument, Measuring, Stereopsis1Product Code
- HLERuler, Nearpoint (Punctometer)1Product Code
- HLFDevice, Measuring, Lens Radius, Ophthalmic1Product Code
- HLGPupillometer, Ac-Powered1Product Code
- HLHPupillometer, Manual1Product Code
- HLIOphthalmoscope, Ac-Powered2Product Code
- HKMRetinoscope, Battery-Powered1Product Code
- HKNRefractor, Manual, Non-Powered, Including Phoropter1Product Code
- HKORefractometer, Ophthalmic1Product Code
- HKQPrism, Rotary, Ophthalmic1Product Code
- HKRLens, Maddox1Product Code
- HKSPrism, Gonioscopic1Product Code
- HKTPrism, Fresnel, Ophthalmic1Product Code
- HKWPrism, Bar, Ophthalmic1Product Code
- KYHEndoscope, Ophthalmic2Product Code
- MPAEndoilluminator2Product Code
- NKZEndoilluminator, Reprocessed2Product Code
- HITTester, Color Vision1Product Code
- HIWAnomaloscope1Product Code
- HIXMaxwell Spot, Ac-Powered1Product Code
- HIYBrush, Haidinger, (Including Macular Integrity)1Product Code
- HJAPhotokeratoscope1Product Code
- HJBInstrument, Measuring, Corneal Radius1Product Code
- HJCEsthesiometer, Ocular1Product Code
- HJDIlluminator, Color Vision Plate1Product Code
- HJILens, Fundus, Hruby, Diagnostic1Product Code
- HJJLens, Fresnel, Flexible, Diagnostic1Product Code
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic2Product Code
- HJLLens, Condensing, Diagnostic1Product Code
- HJMTransilluminator, Ac-Powered2Product Code
- HJNTransilluminator, Battery-Powered1Product Code
- HJOBiomicroscope, Slit-Lamp, Ac-Powered2Product Code
- HJQStereoscope, Ac-Powered1Product Code
- HJRStereoscope, Battery-Powered1Product Code
- HJSTest, Spectacle Dissociation, Ac-Powered (Lancaster)1Product Code
- HJTHaploscope1Product Code
- HJWAdaptometer (Biophotometer)1Product Code
- HKDTape, Nystagmus1Product Code
- HKFMirror, Headband, Ophthalmic1Product Code
- HKGFornixscope1Product Code
- HKICamera, Ophthalmic, Ac-Powered2Product Code
- HKLRetinoscope, Ac-Powered2Product Code
- HLJOphthalmoscope, Battery-Powered2Product Code
- HLKScreen, Tangent, Target, Battery-Powered1Product Code
- HLLMonitor, Eye Movement2Product Code
- HLMInstrument, Measuring, Lens, Ac-Powered1Product Code
- HLNGauge, Lens, Ophthalmic1Product Code
- HLOTest, Spectacle Dissociation, Battery-Powered (Lancaster)1Product Code
- HLPTarget, Fusion And Stereoscopic1Product Code
- HLQKeratoscope, Ac-Powered1Product Code
- HLRKeratoscope, Battery-Powered1Product Code
- HLSExophthalmometer1Product Code
- HLTPreamplifier, Ac-Powered, Ophthalmic2Product Code
- HLWPreamplifier, Battery-Powered, Ophthalmic2Product Code
- HLXPhotostimulator, Ac-Powered2Product Code
- HLZElectrode, Corneal2Product Code
- HMCMonitor, Eye Movement, Diagnostic2Product Code
- HMDChair, Ophthalmic, Manual1Product Code
- HMEChair, Ophthalmic, Ac-Powered1Product Code
- HMFStand, Instrument, Ac-Powered, Ophthalmic1Product Code
- HMGStand, Instrument, Ophthalmic, Non-Powered1Product Code
- HMHRack, Skiascopic1Product Code
- HMJScreen, Tangent, Projection, Battery-Powered1Product Code
- HMKEuthyscope, Ac-Powered2Product Code
- HMLEuthyscope, Battery-Powered1Product Code
- HMMDistometer1Product Code
- HOJScreen, Tangent, Target1Product Code
- HOKScreen, Tangent, Projection, Ac-Powered1Product Code
- HOLScreen, Tangent, Felt (Campimeter)1Product Code
- HOMScreen, Tangent, Ac-Powered (Campimeter)1Product Code
- HONPerimeter, Manual1Product Code
- HOOPerimeter, Ac-Powered1Product Code
- HOPCampimeter, Stereo, Battery-Powered1Product Code
- HOQGrid, Amsler1Product Code
- HORSimulatan (Including Crossed Cylinder)1Product Code
- HOSProjector, Ophthalmic1Product Code
- HOWDrum, Opticokinetic1Product Code
- HOXChart, Visual Acuity1Product Code
- HPAFrame, Trial, Ophthalmic1Product Code
- HPBClip, Lens, Trial, Ophthalmic1Product Code
- HPCSet, Lens, Trial, Ophthalmic1Product Code
- HPDLens, Bagolini1Product Code
- HPJInstrument, Visual Field, Laser2Product Code
- HPKTonograph2Product Code
- HPLDevice, Fixation, Ac-Powered, Ophthalmic1Product Code
- HPTPerimeter, Automatic, Ac-Powered1Product Code
- HPWProbe And Counter, Isotope, For Phosphorus 322Product Code
- HRECabinet, Instrument, Ac-Powered, Ophthalmic1Product Code
- HRIPupillograph1Product Code
- KYDStrip, Schirmer1Product Code
- MMFPhotorefractor2Product Code
- MMQTopographer, Corneal, Ac-Powered1Product Code
- MSGOphthalmoscopes, Replacement Batteries, Hand-Held2Product Code
- MXKDevice, Analysis, Anterior Segment2Product Code
- MYCOphthalmoscope, Laser, Scanning2Product Code
- NCFAberrometer, Ophthalmic1Product Code
- NFDSelector, Color, Spectacle, Lens, Tint1Product Code
- NJGFlasher, Afterimage, Ophthalmic2Product Code
- NJJTonometer, Analyzer, Ocular Blood Flow2Product Code
- NOGTopographer, Corneal, Battery Powered1Product Code
- NOHPhotokeratoscope, Battery Powered1Product Code
- NOIStand, Instrument, Ophthalmic, Battery Powered1Product Code
- NQEMicroscope, Specular2Product Code
- NXRFixation, Vision Training, Binocular1Product Code
- NYKOphthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)2Product Code
- OBOTomography, Optical Coherence2Product Code
- OUMAdaptometer (Biophotometer), Software-Based Data Acquisition And Stimulus Generation1Product Code
- PIBDiabetic Retinopathy Detection Device2Product Code
- PJZCamera, Ophthalmic, General-Use2Product Code
- PLZOcular Pattern Recorder2Product Code
- PMWStrabismus Detection Device2Product Code
- PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt2Product Code
- QERCamera, Ophthalmic, Slit-Scanning2Product Code
- NFFDevice, Storage, Images, Ophthalmic1Product Code
- NFGDevice, Communications, Images, Ophthalmic1Product Code
- NFHDigitizer, Images, Ophthalmic2Product Code
- NFIDevice, Hardcopy, Images, Ophthalmic2Product Code
- NFJSystem, Image Management, Ophthalmic2Product Code
- QTODigital Visual Acuity Test1Product Code
- QTWDigital Amsler Grid1Product Code
- QZPCamera, Ophthalmic, Non-Prescription2Product Code
- SBIManual Refractor, 3d Display1Product Code
- SBNDigital Therapy Device For Convergence Insufficiency1Product Code
- SCWDigital Prismatic Correction1Product Code
- 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—Therapeutic DevicesCFR Sub-Part
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ACCUPEN
- Page Type
- Cleared 510(K)
- 510(k) Number
- K083377
- 510(k) Type
- Traditional
- Applicant
- ACCUTOME ULTRASOUND, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/27/2009
- Days to Decision
- 255 days
- Submission Type
- Statement