Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- ETKTube, Toynbee Diagnostic1Product Code
- ETMGustometer, Sterile1Product Code
- ETNStimulator, Nerve2Product Code
- ETPStimulator, Caloric-Water1Product Code
- ETRAdaptor, Short Increment Sensitivity Index (Sisi)1Product Code
- ETSGenerator, Electronic Noise (For Audiometric Testing)2Product Code
- ETTCushion, Earphone (For Audiometric Testing)1Product Code
- ETYTester, Auditory Impedance2Product Code
- K183201Hearing Healthcare Pro2Cleared 510(K)
- K171038Hearing Healthcare Pro2Cleared 510(K)
- K162210touchTymp2Cleared 510(K)
- K161707Madsen Zodiac2Cleared 510(K)
- K151616AT2352Cleared 510(K)
- K151509GSI TympStar Pro Middle Ear Analyzer2Cleared 510(K)
- K133013INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE2Cleared 510(K)
- K121847TITAN2Cleared 510(K)
- K083861TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE2Cleared 510(K)
- K081841AMPLIVOX OTOWAVE 102 HAND HELD PORTABLE TYMPANOMETER2Cleared 510(K)
- K070312EARCHECK ACOUSTIC REFLECTOMETER2Cleared 510(K)
- K033645OTOFLEX 100 TYE 10122Cleared 510(K)
- K031978AMPLAID A756 SCREENING ADMITTANCE METER2Cleared 510(K)
- K022728AUDIOTRAVELLER, MODEL AA2222Cleared 510(K)
- K000097GSI 2000 MIDDLE EAR ANALYZER2Cleared 510(K)
- K994254INTERACOUSTICS AT235 IMPEDANCE AUDIOMETER2Cleared 510(K)
- K991562PASCAL MEDICAL AB MENIETT 202Cleared 510(K)
- K992370AMPLAID A724 AND A7282Cleared 510(K)
- K990652INTERACOUSTICS MODEL AZ26 CLINICAL IMPEDANCE AUDIOMETER2Cleared 510(K)
- K990585INTERACOUSTICS AT22T AUTOMATIC IMPEDANCE AUDIOMETER2Cleared 510(K)
- K983832INTERACOUSTICS MODEL MT 10, HANDHELD IMPEDANCE AUDIOMETER2Cleared 510(K)
- K983049AMERICAN ELECTROMEDICS QUIK TYMP 1 (QT1) TYMPANOMETER WITH INTERGRAL PRINTER2Cleared 510(K)
- K983051AMERICAN ELECTROMEDICS RACE CA TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER2Cleared 510(K)
- K983046AMERICAN ELECTROMEDICS RACE CAR TYMPANOMETER W/INTEGRAL PRINTER2Cleared 510(K)
- K974235AMPLAID AM502Cleared 510(K)
- K971859EARCHECK2Cleared 510(K)
- K970685EARCHECK PRO2Cleared 510(K)
- K955289RACE CAR TYMPANOMETER2Cleared 510(K)
- K953161MAICO MA630D AUDIOMETER WITH OPTIONAL REFLEX DECAY & EUSTACHIAN TUBE FUNCTION2Cleared 510(K)
- K942008INTERACOUSTICS AUTOMATIC IMPEDANCE AUDIOMETER2Cleared 510(K)
- K942007INTERACOUSTICS CLINICAL IMPEDANCE AUDIOMETER AZ262Cleared 510(K)
- K930165AE-207D TYMPANOMETER2Cleared 510(K)
- K930164THE AUTOMATIC IMPEDANCE METER,MODEL AE-208D/S2Cleared 510(K)
- K923072HANDTYMP2Cleared 510(K)
- K923073AUTOMATIC TYMPANOMETER2Cleared 510(K)
- K925585GSI 38 AUTO TYMP2Cleared 510(K)
- K924933AE-206 TYMPNOMWRWE(R) AUDIOMETER2Cleared 510(K)
- K924934AUTOMATIC IMPEDANCE METER AE-2052Cleared 510(K)
- K910247ZODIAC 901 MIDDLE-EAR ANALYZER2Cleared 510(K)
- K905704MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER2Cleared 510(K)
- K911095GSI 37 AUTO TYMP2Cleared 510(K)
- K905213MIDDLE EAR ANALYZER, MODEL AE-8032Cleared 510(K)
- K905212IMMITTANCE METER, MODEL AE-105D/S2Cleared 510(K)
- K903066AMPLAID 770 ADMITTANCE METER2Cleared 510(K)
- K894260AE-105D DIAGNOSTIC TYMPANOMETER2Cleared 510(K)
- K895443MODEL 210 IMPEDANCE SYSTEM2Cleared 510(K)
- K895783IMPEDANCE ANALYZER MODELS MD-2, MD-P2Cleared 510(K)
- K890864HANDTYMP SCREENER MODEL 2000 + 2002 REMOTE TRANS.2Cleared 510(K)
- K883293STORZ DX CENTER:IMPEDANCE TEST W/RHINO & AUDIO OPT2Cleared 510(K)
- K883728AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER2Cleared 510(K)
- K874354AUDIOMETRIC IMPEDANCE TESTER, MODEL Z020202Cleared 510(K)
- K871652NEUROCOM PRESSURE TEST SYSTEM2Cleared 510(K)
- K863353MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER)2Cleared 510(K)
- K861516WELCH ALLYN TYMPANOMETER2Cleared 510(K)
- K860262TA-6C - PART NUMBER SLZ 75202Cleared 510(K)
- K854043AUTOMATIC IMPEDANCE AUDIOMETER, TA-7B2Cleared 510(K)
- K853863MODEL 310 IMPEDANCE SYSTEM2Cleared 510(K)
- K845049Z0174, IMPEDANCE AUDIOMETER2Cleared 510(K)
- K850461AUTOMATIC IMPEDANCE METER TA-7A2Cleared 510(K)
- K850007ACOUSTIC OTOCOPE RECORDER2Cleared 510(K)
- K841568IMPEDANCE/PURE TONE AUDIOMETER MA6202Cleared 510(K)
- K833045CLINICAL TYMPANOMETER2Cleared 510(K)
- K831754MA 610-IMPEDANCE AUDIOMETER2Cleared 510(K)
- K831755MA600-IMPEDANCE AUDIOMETER2Cleared 510(K)
- K830139ENDECO ACOUSTIC OTOSCOPE2Cleared 510(K)
- K823227IMPEDANCE METER ON-12Cleared 510(K)
- K822566AURAL REFLEX INDICATOR2Cleared 510(K)
- K811509AUTO-TYMPANIGRAPH (TA-5A)2Cleared 510(K)
- K802097SELF-RECORDING ADMITTANCE METER 7092Cleared 510(K)
- K801293ACOUSTIC IMPEDANCE METER, MODEL TA-4D2Cleared 510(K)
- EWASet, Audiometer Calibration1Product Code
- EWCChamber, Acoustic (For Audiometric Testing)1Product Code
- EWOAudiometer2Product Code
- KHHStimulator, Caloric-Air1Product Code
- KLXElectroglottograph2Product Code
- LYNApparatus, Visual Reinforcement Audiometric2Product Code
- NASTympanometer2Product Code
- NNJGustometer, Non-Sterile1Product Code
- NRKKit, Test, Olfactory2Product Code
- PTOTester, Auditory Impedance, Exempt2Product Code
- PTPTympanometer, Exempt2Product Code
- LWIUltrasound, Sinus2Product Code
- PSVUltrasound Bronchoscope2Product Code
- QJGDevice System, Imaging, Tympanic Membrane And Middle Ear2Product Code
- QQEImage Management Software For Planning Of Otologic And Neurotologic Procedures2Product Code
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical 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
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- 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
OTOFLEX 100 TYE 1012
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K033645
- 510(k) Type
- Traditional
- Applicant
- Gn Otometrics A/S
- Country
- Denmark
- FDA Decision
- Substantially Equivalent
- Decision Date
- 3/31/2004
- Days to Decision
- 132 days
- Submission Type
- Summary