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
- EWASet, Audiometer Calibration1Product Code
- EWCChamber, Acoustic (For Audiometric Testing)1Product Code
- EWOAudiometer2Product Code
- K234095OtoNova/OtoNova Pro2Cleared 510(K)
- K240430Otoport Pro2Cleared 510(K)
- K231545hearOAE2Cleared 510(K)
- K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE2Cleared 510(K)
- K191372Lyra2Cleared 510(K)
- K180287GSI Corti2Cleared 510(K)
- K173567Sera2Cleared 510(K)
- K172403GSI Novus2Cleared 510(K)
- K171506Easyscreen2Cleared 510(K)
- K151025iHearTest2Cleared 510(K)
- K150491ER36 Series OAE Test System2Cleared 510(K)
- K141524NEURO-AUDIO2Cleared 510(K)
- K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit2Cleared 510(K)
- K133012SENTIERO2Cleared 510(K)
- K130795TITAN2Cleared 510(K)
- K123624OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM2Cleared 510(K)
- K122496AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM2Cleared 510(K)
- K121512SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM2Cleared 510(K)
- K112992EARLOGIC OAE TESTER2Cleared 510(K)
- K112247A BAER WITH ABAER I/O FUNCTION2Cleared 510(K)
- K111618AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION2Cleared 510(K)
- K112733ER35 ERO-SCAN PRO HEARING TEST SYSTEM2Cleared 510(K)
- K103298ACAM 5 AUDIOMETER SYSTEM2Cleared 510(K)
- K092089CLARUJUST2Cleared 510(K)
- K092244MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS2Cleared 510(K)
- K092111ENTOMED SCREENING AUDIOMETER, MODEL SA201,SA202, ENTOMED DIAGNOSTIC AUDIOMETER MODEL SA203,SA2042Cleared 510(K)
- K090406EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE2Cleared 510(K)
- K081234GN OTOMETRICS INSERT EARPHONES2Cleared 510(K)
- K072033OTODYNAMICS OTOPORT2Cleared 510(K)
- K070880ER35 ERO-SCAN PRO HEARING TEST SYSTEM2Cleared 510(K)
- K063452MA 55 MAESTRO2Cleared 510(K)
- K070118OTOGRAM, CA33502Cleared 510(K)
- K063338HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER2Cleared 510(K)
- K061744COCHLEA-SCAN / COCHLEA-SCAN PLUS2Cleared 510(K)
- K060883PILOT TEST OR DETECTIVE AUDIOMETERS2Cleared 510(K)
- K060885MODEL MI 44 TYMPANOMETER2Cleared 510(K)
- K060539DPOAE20 , ECLIPSE2Cleared 510(K)
- K053216HEARID WIDEBAND MIDDLE EAR POWER ANALYZER2Cleared 510(K)
- K052562ECLIPSE (CABINET NAME), TEOAE25, EP15, OR THE COMBINATION OF SYSTEMS.2Cleared 510(K)
- K043219AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS2Cleared 510(K)
- K033108VIVO 200 DPS VIVOSCAN VERSION 2.0 OAE AUDIOMETER2Cleared 510(K)
- K031713AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS2Cleared 510(K)
- K031986ICS MEDICAL CHARTR EP WITH ASSR AND CHARTR OAE SYSTEMS2Cleared 510(K)
- K031352BIO-LOGIC INSERT EARPHONES2Cleared 510(K)
- K030016TEOAE252Cleared 510(K)
- K024205AUDIOSCREENER OAE+ABR2Cleared 510(K)
- K023859SMARTTROAE2Cleared 510(K)
- K021801BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS2Cleared 510(K)
- K011135GSI AUDERA2Cleared 510(K)
- K003364VIVO 200 DPS VIVOSCAN2Cleared 510(K)
- K011114ETYMOTIC RESEARCH ER-10D OAE PROBE2Cleared 510(K)
- K011181ICS MEDICAL CHARTR OAE WITH TYMP2Cleared 510(K)
- K003913HINT AUDIOMETER, OR HINT2Cleared 510(K)
- K010165ERO SCAN OAE TEST SYSTEM2Cleared 510(K)
- K002200CAPELLA2Cleared 510(K)
- K001058AUDIOSCREENER OAE + ABR2Cleared 510(K)
- K994033HORTMANN ECHOMASTER OAE ANALYZER2Cleared 510(K)
- K000184AUDIOSCREENER OAE2Cleared 510(K)
- K984547DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS2Cleared 510(K)
- K983915AMPLAID A315 AND A3192Cleared 510(K)
- K983851CAPELLA COCHLEAR EMISSIONS ANALYZER2Cleared 510(K)
- K983712AMPLAID A311 SERIES2Cleared 510(K)
- K983352ILO2088 ENCHOCHECK OR ILO2088 OTOCHECK2Cleared 510(K)
- K983350ILO292 DP ECHOPORT PLUS OAE SYSTEM2Cleared 510(K)
- K983351ILO292 DP ECHOPORT PLUS OAE SYSTEM2Cleared 510(K)
- K983048AMERICAN ELECTROMEDICS QUIK TYMP 2 (QT2) TYMPANOMETER/AUDIOMETER WITH INTEGRAL PRINTER2Cleared 510(K)
- K982878EARSCAN 32Cleared 510(K)
- K982723MAICO MA422Cleared 510(K)
- K982642ECHO-SCREEN2Cleared 510(K)
- K982566AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM)2Cleared 510(K)
- K982441CCA-2202Cleared 510(K)
- K982249INTERACOUSTICS MODEL AD229 DIAGNOSTIC AUDIOMETER2Cleared 510(K)
- K981511OTO WIZZARD2Cleared 510(K)
- K981439CCA-2002Cleared 510(K)
- K981460CUB DIS II DPOAE MEASUREMENT SYSTEM2Cleared 510(K)
- K981327INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER2Cleared 510(K)
- K981142MAICO MA532Cleared 510(K)
- K980505HORTMANN AMDIS-OAE OAE ANALYZER2Cleared 510(K)
- K980533ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)2Cleared 510(K)
- K973377SIBELMED AC50D2Cleared 510(K)
- K974237GSI 70 AUDIOPATH SCREENER2Cleared 510(K)
- K974076SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE2Cleared 510(K)
- K973320ARTICULATE FITTING SYSTEM2Cleared 510(K)
- K972862AMPLAID 171S2Cleared 510(K)
- K972221K 15 AUDIOMETER2Cleared 510(K)
- K971747AMPLAID 4602Cleared 510(K)
- K971080MAICO MA522Cleared 510(K)
- K964132MODIFICATION TO OTOACOUSTIC EMISSIONS (OAE0 TEST INSTRUMENT2Cleared 510(K)
- K970279RACE CAR TYMPANOMETER WITH AUDIOMETER(AE-RCAUD I/QUIK TYMP 1(AE-QUIK 1)/QUICK TYMP 2(AE-QUIK 2)2Cleared 510(K)
- K970555IL0292 DP ECHOPORT2Cleared 510(K)
- K964426SMARTOAE2Cleared 510(K)
- K964340PORTAREM-3000, PFS-60002Cleared 510(K)
- K962995ILO88. OTODYNAMIC ANALYSER, KIT SYSTEM FOR PC2Cleared 510(K)
- K963681CCA-100 (MODIFIED)2Cleared 510(K)
- K962275MAICO MA25 SERIES II WITH SPEECH2Cleared 510(K)
- K962012ETHICAL HEARING INSTRUMENTS/WIZARD HEARING PROFILE TESTER2Cleared 510(K)
- K961447SCOUT SPORT - A MODIFICATION TO (FORMERLY EMAV) OTOACOUSTIC EMISSIONS (OAE) TEST INSTRUMENT2Cleared 510(K)
- K953814OTOSCAPE2Cleared 510(K)
- K953884PROPHET2Cleared 510(K)
- K953684GSI 61 CLINICAL AUDIOMETER2Cleared 510(K)
- K943616BELTONE PERSONAL HEARING SCREENER2Cleared 510(K)
- K951759GSI 65 COMPUTERIZED AUDIOMETER2Cleared 510(K)
- K943215DISPOSABLE AUDIOMETER EARPHONE CUSHION COVER2Cleared 510(K)
- K951527THE PILOT AUDIOMETER2Cleared 510(K)
- K945199RH2000 REAL EAR MEASUREMENT SYSTEM2Cleared 510(K)
- K950888SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY2Cleared 510(K)
- K945689GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM) 2000 PERSONAL DIGITAL AUDIOMETER(TM)2Cleared 510(K)
- K945032VOYAGER 5222Cleared 510(K)
- K944735BIO-LOGIC EMAV EMISSION AVERAGING OTOACOUSTIC TEST2Cleared 510(K)
- K941920INTERACOUSTICS CLINICAL AUDIOMETER2Cleared 510(K)
- K942716AUDIO EXPERT AUDIOMETER2Cleared 510(K)
- K943066INTERACOUSTICS COMPUTER AUDIOMETER BA 202Cleared 510(K)
- K931322KS 5 - CLINICAL AUDIOMETER2Cleared 510(K)
- K943065INTERACOUSTICS CLINICAL AUDIOMETER2Cleared 510(K)
- K940216BELTONE SERIES 100 AUDIOMETERS2Cleared 510(K)
- K935719DAIL A HEARING SCREENING TEST2Cleared 510(K)
- K942006INTERACOUSTICS DIAGNOSTIC AUDIOMETER2Cleared 510(K)
- K934715MODEL 222 CLINICAL AUDIOMETER2Cleared 510(K)
- K940999PRODIGIT 20002Cleared 510(K)
- K931325OTOACOUSTIC EMISSIONS UNIT CELESTA 5032Cleared 510(K)
- K935348ODYSSEY CLINICAL AUDIOMETER2Cleared 510(K)
- K934658GSI 60 DPOAE SYSTEM2Cleared 510(K)
- K933097SOUND SELECTOR FULL-SERVICE AUDIOMETER2Cleared 510(K)
- K934343GLASER RT60, RT80, RT150 AUDIOMETER2Cleared 510(K)
- K933220SELECTOR SL 012Cleared 510(K)
- K931324ORBITER 922 CLINICAL AUDIOMETER2Cleared 510(K)
- K933222AUDIOMETER DA 3232Cleared 510(K)
- K930553CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT2Cleared 510(K)
- K930112MAICO MA790 AUDIOMETER2Cleared 510(K)
- K926439MA25 - PORTABLE AUDIOMETER, MODIFICATION2Cleared 510(K)
- K930260ACOUSTIC ANALYZER AA302Cleared 510(K)
- K930003TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES2Cleared 510(K)
- K926336AUDIOSCAN2Cleared 510(K)
- K924543DSP SCREENING AUDIOMETER2Cleared 510(K)
- K923007AT-22Cleared 510(K)
- K922383THE MONITOR MODEL MI-1.2.3 TONE COUNT SCREEN AUDIO2Cleared 510(K)
- K922746ST 20 PORTABLE AUDIOMETER2Cleared 510(K)
- K923074DANPLEX SCREENING AUDIOMETER2Cleared 510(K)
- K923013ACOUSTIC APPRAISE CD-32Cleared 510(K)
- K921085PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)2Cleared 510(K)
- K915323THE BELTONE AUDIO SCOUT2Cleared 510(K)
- K914232ASRA, SCREENING AUDIOMETER2Cleared 510(K)
- K913356THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER2Cleared 510(K)
- K913589EARSCAN DSP-1 PURE TONE AUDIOMETER2Cleared 510(K)
- K913276MICROTEK MEDICAL'S SOUND STIKS2Cleared 510(K)
- K911689MODEL 330 SCREENING AUDIOMETER2Cleared 510(K)
- K913221TYPE FA10 AUDIOMETER2Cleared 510(K)
- K904622HEARING CHECKER(TM), DESKTOP MODEL2Cleared 510(K)
- K912669RESOUND PORTABLE PRESCRIPTIVE PROGRAMMING SYSTEM2Cleared 510(K)
- K911368MAICO MA800 AUDIOMETER2Cleared 510(K)
- K900197THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER2Cleared 510(K)
- K904544ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID2Cleared 510(K)
- K904270BIOLINK AUDIOMETER SOFTWARE ACCESSORY2Cleared 510(K)
- K903143OTOSCREENER-I AND OTO-SCREEN-I-P2Cleared 510(K)
- K902068HEARING AMBASSADOR-HEAR PEN SCREENING AUDIOMETER2Cleared 510(K)
- K902540GSI 17 SCREENING AUDIOMETER2Cleared 510(K)
- K894484AUDIOTESTER SCREENING AUDIOMETER2Cleared 510(K)
- K900096INTELLIGENT VISUAL REINFORCEMENT AUDIOMETRY (IVRA)2Cleared 510(K)
- K896710MIDIMATE 6222Cleared 510(K)
- K896401MICROMATE 3042Cleared 510(K)
- K896909MD5 AUTOMATIC AUDIOMETER2Cleared 510(K)
- K895310AUDIOMETER/MASTER HEARING AID, MAICO MODEL MF72Cleared 510(K)
- K895200MODEL EB-22 NOISE STIK2Cleared 510(K)
- K895784IMPEDANCE ANALYZER/AUDIOMETER MODEL MD-32Cleared 510(K)
- K895785AUDIOMETER MODEL MD-4, MD-4P2Cleared 510(K)
- K894748IMPEDANCE ANAL/SCREENING AUDIOMETER MD-1 & MD-1P2Cleared 510(K)
- K891988AMPLAID A308 CLINICAL AUDIOMETER2Cleared 510(K)
- K890993AUDIOMETER AI1, ME1 AND SA1 & MASTER HEARING AID2Cleared 510(K)
- K883505BIOMETER AUDIOMETER2Cleared 510(K)
- K891373TRACOR RA500 AUDIOMETER2Cleared 510(K)
- K890124ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER2Cleared 510(K)
- K8908422400 AUDIOMETER, IMPEDANCE METER & HRNG. AID ANALY2Cleared 510(K)
- K890497MODEL 20-P EXTENDED HIGH FREQUENCY AUDIOMETER2Cleared 510(K)
- K884218AUDIOSCOPE 3 MODEL 23300 ACCESSORIES2Cleared 510(K)
- K884044AUDIOMETER DIGITAL HEARING SYSTEM2Cleared 510(K)
- K883169OTOMETER PORTABLE SCREENING AUDIOMETER2Cleared 510(K)
- K883478DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 6022Cleared 510(K)
- K881760AE1162 CLINICAL/DIAGNOSTIC AUDIOMETER2Cleared 510(K)
- K880059AMPLAID 309 CLINICAL AUDIOMETER2Cleared 510(K)
- K875360THE BELTONE 2000 AUDIOMETER2Cleared 510(K)
- K874516MODEL V4 AUDIOMETER2Cleared 510(K)
- K872042PLAYTONE AUDIOMETER2Cleared 510(K)
- K863979MICROSCREEN I HEARING TESTER2Cleared 510(K)
- K863984MODEL 320 TWO CHANNEL AUDIOMETER2Cleared 510(K)
- K862592PHOENIX SYSTEM SEVEN.2Cleared 510(K)
- K862770AUDIOMETER/MASTER HEARING AID MF62Cleared 510(K)
- K854835DAHLBERG MODEL GF MICROPROCESSOR AUDIOMETER2Cleared 510(K)
- K854534DIGITAL SCREENING AUDIOMETER DSA62142Cleared 510(K)
- K854125CRAIGWELL AID FITTING SYSTEM AFS2Cleared 510(K)
- K853919MA25 PORTABLE AUDIOMETER2Cleared 510(K)
- K853245TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER2Cleared 510(K)
- K851392TRACOR 200 MICROPROCESSOR AUDIOMETER/TRACOR RA 2002Cleared 510(K)
- K851015TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER2Cleared 510(K)
- K845050UP800 A UNIVERSAL PRINTER2Cleared 510(K)
- K844069TA-201 CLINICAL AUDIOMETER2Cleared 510(K)
- K843618AUDIOMETER2Cleared 510(K)
- K841567AUDIOMETER MA7282Cleared 510(K)
- K841167DEMLAR SYS I COMPUTER BASED AUDIOMETER2Cleared 510(K)
- K833883DIGITAL AUDIOMETER/HEARING AID 31002Cleared 510(K)
- K831431AUDIOMETER MODEL-5002Cleared 510(K)
- K822335AUDIT2Cleared 510(K)
- K823554ACOH WELLNESS TESTER2Cleared 510(K)
- K822745THE SCREENING TYMPANOMETER2Cleared 510(K)
- K822414TRACOR RA400 AUDIOMETER2Cleared 510(K)
- K820715MIDDLE EAR ANALYZER (IMPEDANCE AUDIO2Cleared 510(K)
- K812529EARSCAN2Cleared 510(K)
- K811727PORTABLE AUDIOMETERS2Cleared 510(K)
- K810583AUDIOMETER2Cleared 510(K)
- K810537AUTOMATIC SCREENING AUDIOMETER2Cleared 510(K)
- K803072HIGH FREQUENCY AUDIOMETER DELMAR #20-K2Cleared 510(K)
- K802963101, 151, 161 PORTABLE AUDIOMETERS2Cleared 510(K)
- K802560TINNITUS RESEARCH AUDIOMETER2Cleared 510(K)
- K802350ATTENU-CHEK2Cleared 510(K)
- K802207RION DIAGNOSTIC AUDIOMETER2Cleared 510(K)
- K801325CLINICAL AUDIOMETER MODEL TA-2002Cleared 510(K)
- K791467TA-10 PORTABLE SCREENING AUDIOMETER2Cleared 510(K)
- K790878SCREENING AUDIOMETER, HIGH FREQUENCY2Cleared 510(K)
- K791170MIS AURAL ACOUSTIC SCREENER2Cleared 510(K)
- K790903TRACOR MODEL RA-411 MICROPROCESSOR2Cleared 510(K)
- K790846MIDDLE EAR ANALYZER (IMPED. AUDIOMTR)2Cleared 510(K)
- K790609AUDIOMETER2Cleared 510(K)
- K781474PREAMPLIFIER MODELS 8101PI & 8102PI2Cleared 510(K)
- K780749SPEECH AUDIOMETER RA 2262Cleared 510(K)
- K780450TRACOR RA 410 AUDIOMETER2Cleared 510(K)
- K780382AUDIOMETER, PORTABLE, AIR CONDUCTION2Cleared 510(K)
- K780269COMPUTER AUDIOMETER - MA252Cleared 510(K)
- K780270COMPUTER AUDIOMETER - MA262Cleared 510(K)
- K780150NEONATAL SCREENING AUDIOMETER2Cleared 510(K)
- K772169AUDIOMETER, RECORDING, AUTOMATIC2Cleared 510(K)
- K770823AUDIOMETRIC TESTING SYS., SERIES 5002Cleared 510(K)
- K770616AUDIOMETER, MA29, PURE TONE AIR CONDUCT.2Cleared 510(K)
- K770618AUDIOMETER, MA312Cleared 510(K)
- K770617AUDIOMETER, MA30, AIR & BONE CONDUCTION2Cleared 510(K)
- K770553AUDIOMETER, DIAG., ADVANCED, MA-222Cleared 510(K)
- K760859TRACOR MODEL RA 208 COMPLIANCE AUDIOM2Cleared 510(K)
- 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
ARTICULATE FITTING SYSTEM
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K973320
- 510(k) Type
- Traditional
- Applicant
- DECIBEL INSTRUMENTS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/25/1997
- Days to Decision
- 83 days
- Submission Type
- Summary