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
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- GXWEchoencephalograph2Product Code
- GXXBlock, Test, Ultrasonic Scanner Calibration1Product Code
- GXYElectrode, Cutaneous2Product Code
- GXZElectrode, Needle2Product Code
- GYATester, Electrode/Lead, Electroencephalograph1Product Code
- GXSMonitor, Alpha2Product Code
- GWEStimulator, Photic, Evoked Response2Product Code
- GWFStimulator, Electrical, Evoked Response2Product Code
- GWGEndoscope, Neurological2Product Code
- GWIDiscriminator, Two-Point1Product Code
- GWJStimulator, Auditory, Evoked Response2Product Code
- K242954Integrity V500 (Integrity, Integrity with VEMP)2Cleared 510(K)
- K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)2Cleared 510(K)
- K220139QScreen2Cleared 510(K)
- K211147ALGO 7i2Cleared 510(K)
- K193033GSI Audera Pro2Cleared 510(K)
- K163326SmartEP2Cleared 510(K)
- K162037Eclipse with VEMP2Cleared 510(K)
- K143670ICS CHARTR EP 200 WITH VEMP2Cleared 510(K)
- K141446ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO HEARING SCREENER WITHOUT BARCODE SCANNER,2Cleared 510(K)
- K132957MADSEN ACCUSCREEN TYPE 10772Cleared 510(K)
- K131141EARPROBE2Cleared 510(K)
- K123701HEARLAB ACA2Cleared 510(K)
- K122067TYPE 1077 ACCUSCREEN2Cleared 510(K)
- K111555CIRCUMAURAL ADHESIVE REPLACEMENT2Cleared 510(K)
- K103760TITAN2Cleared 510(K)
- K100661EARPROBE2Cleared 510(K)
- K092373ICS CHARTR EP 2002Cleared 510(K)
- K090579SMARTSCREENER-PLUS22Cleared 510(K)
- K083399ICS CHARTR EP 2002Cleared 510(K)
- K082035MAICO MB 11 WITH BERAPHONE PROBE2Cleared 510(K)
- K080060VIVOSONIC NEUROSCREEN2Cleared 510(K)
- K073384SMART COUPLER, MODEL M0154012Cleared 510(K)
- K073626BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM2Cleared 510(K)
- K073665ALGO 5 NEWBORN HEARING SCREENER2Cleared 510(K)
- K070608SMARTEP, MODEL M0100002Cleared 510(K)
- K070696INTERACOUSTICS ASSR, ECLIPSE SYSTEM (CABINET NAME)2Cleared 510(K)
- K061443SMART USBLITE, MODEL M0111202Cleared 510(K)
- K043396INTEGRITY, MODEL V5002Cleared 510(K)
- K031051SMARTEP-ASSR, MODEL M8110072Cleared 510(K)
- K030907STACKED ABR FOR NAVIGATOR PRO2Cleared 510(K)
- K031009MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM2Cleared 510(K)
- K030823ALGO 3I NEWBORN HEARING SCREENER2Cleared 510(K)
- K021895BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM2Cleared 510(K)
- K013977ECHO-SCREEN T, TA, TD, TDA, TC2Cleared 510(K)
- K021215BIO-LOGIC ABAER CUB2Cleared 510(K)
- K011842SABRE COMPAC2Cleared 510(K)
- K012415AURIS AEP2Cleared 510(K)
- K013137ALGO 3 NEWBORN HEARING SCREENER2Cleared 510(K)
- K011746MB 112Cleared 510(K)
- K002985ICS MEDICAL CHARTR EP AND CHARTR OAE SYSTEMS2Cleared 510(K)
- K994149MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL FOR ABAER/ NAVIGATOR PRO.2Cleared 510(K)
- K993177SABRE2Cleared 510(K)
- K991853INTERACOUSTICS EP 15 ABR STAND ALONE UNIT2Cleared 510(K)
- K992807BIO-LOGIC EVOKED POTENTIAL FOR ABAER I2Cleared 510(K)
- K972157EXCEL AV STIM 10002Cleared 510(K)
- K960097CHARTR EP2Cleared 510(K)
- K953732TECA PREMIERE2Cleared 510(K)
- K952080CLARITY SYSTEM II2Cleared 510(K)
- K936039ALGO-2 NEWBORN HEARING SCREENER2Cleared 510(K)
- K925648SMART-SCREENER (AUDITORY)2Cleared 510(K)
- K926574MODEL 330 SCREENING AUDIO METER, MODIFIED2Cleared 510(K)
- K913957DANTEC COUNTERPOINT MK2(TM)2Cleared 510(K)
- K913785CORONET 1002Cleared 510(K)
- K904926SMART-EP2Cleared 510(K)
- K905632NICOLET MAPLELEAF SYSTEM2Cleared 510(K)
- K874193MICROSHEV MODEL 20002Cleared 510(K)
- K870030THE SCREENER GSI 55 ABR SCREENER2Cleared 510(K)
- K862906TECA/MEDELEC AS-10 SENSOR2Cleared 510(K)
- K863156TECA/MEDELEC AUDIOSTAR2Cleared 510(K)
- K863985EVOPORT 1002Cleared 510(K)
- K862430SIEGEN HEADPHONES2Cleared 510(K)
- K86236140-HZ AUDITORY EVOKED RESPONSE TEST2Cleared 510(K)
- K862363INSERT EARPHONES2Cleared 510(K)
- K852687ALGO I2Cleared 510(K)
- K832510EVOKED POTENTIALS SYSTEM MK102Cleared 510(K)
- K830579MULTI-SIGNAL AUDITORY STIMULATOR SM7002Cleared 510(K)
- K822177AUDIOMETERS (VARIOUS MODELS)2Cleared 510(K)
- K813009TECA VISUAL/AUDIO STIMULATOR MODEL CS-22Cleared 510(K)
- K810473MK6 ERA SYSTEM2Cleared 510(K)
- K810138SYNAP-I INFANT SENSORY ASSESSMENT UNIT2Cleared 510(K)
- K810539MODEL S10CTCM AUDITORY STIMULATOR2Cleared 510(K)
- K792085C-ERA-100 COMPUTERIZED ELECTRIC RESPON2Cleared 510(K)
- K781667AMPLAID MARK 4 AND MARK 52Cleared 510(K)
- K780540ELECTRIC RESPONSE AUDIOMETER2Cleared 510(K)
- K770878SIGNAL PROCESSOR/AVERAGER MODEL 7S112Cleared 510(K)
- K770268SYS. FOR REC. BSER RESPONSES2Cleared 510(K)
- GWKConditioner, Signal, Physiological2Product Code
- GWLAmplifier, Physiological Signal2Product Code
- GWMDevice, Monitoring, Intracranial Pressure2Product Code
- GWNNystagmograph2Product Code
- GWQFull-Montage Standard Electroencephalograph2Product Code
- GWRGenerator, Electroencephalograph Test Signal1Product Code
- GWSAnalyzer, Spectrum, Electroencephalogram Signal1Product Code
- GWWAtaxiagraph1Product Code
- GWXFork, Tuning1Product Code
- GWYPinwheel1Product Code
- GWZPercussor1Product Code
- GXBEsthesiometer1Product Code
- GYBMedia, Electroconductive2Product Code
- GYCElectrode, Cortical2Product Code
- GYDTransducer, Tremor2Product Code
- GYEEncephalogram Telemetry System2Product Code
- GZKElectrode, Nasopharyngeal2Product Code
- GZLElectrode, Depth2Product Code
- GZMAnalyzer, Rigidity2Product Code
- GZNRheoencephalograph3Product Code
- GZODevice, Galvanic Skin Response Measurement2Product Code
- GZPStimulator, Mechanical, Evoked Response2Product Code
- HCJDevice, Skin Potential Measurement2Product Code
- HCSDevice, Temperature Measurement, Direct Contact, Powered2Product Code
- JXEDevice, Nerve Conduction Velocity Measurement2Product Code
- JXFPlethysmograph, Ocular3Product Code
- LLNDevice, Vibration Threshold Measurement1Product Code
- LQWTest, Temperature Discrimination1Product Code
- NCGNeuropsychiatric Interpretative Electroencephalograph Assessment Aid2Product Code
- NTUEvoked Potential Stimulator, Thermal2Product Code
- OLTNon-Normalizing Quantitative Electroencephalograph Software2Product Code
- OLUNormalizing Quantitative Electroencephalograph Software2Product Code
- OLVStandard Polysomnograph With Electroencephalograph2Product Code
- OLWIndex-Generating Electroencephalograph Software2Product Code
- OLXSource Localization Software For Electroencephalograph Or Magnetoencephalograph2Product Code
- OLYMagnetoencephalograph2Product Code
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph2Product Code
- OMAAmplitude-Integrated Electroencephalograph2Product Code
- OMBAutomatic Event Detection Software For Full-Montage Electroencephalograph2Product Code
- OMCReduced- Montage Standard Electroencephalograph2Product Code
- ORTBurst Suppression Detection Software For Electroencephalograph2Product Code
- PIWBrain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid2Product Code
- PKQComputerized Cognitive Assessment Aid2Product Code
- PNAEvoked Photon Image Capture Device1Product Code
- POMComputerized Cognitive Assessment Aid For Concussion2Product Code
- POPCranial Motion Measurement Device2Product Code
- POSPhysiological Signal Based Seizure Monitoring System2Product Code
- PSPIntracranial Pressure & Temperature Monitoring Kit2Product Code
- PTBAtaxiagraph With Interpretive Software1Product Code
- PTYComputerized Cognitive Assessment Aid, Exempt2Product Code
- PVPNeurological Test Kit1Product Code
- QEABrain Injury Adjunctive Interpretive Oculomotor Assessment Aid2Product Code
- QPFPediatric Autism Spectrum Disorder Diagnosis Aid2Product Code
- OPTInfrared Hematoma Detector2Product Code
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular 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
- 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
ICS CHARTR EP 200
- Page Type
- Cleared 510(K)
- 510(k) Number
- K083399
- 510(k) Type
- Traditional
- Applicant
- GN OTOMETRICS A/S
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 2/20/2009
- Days to Decision
- 95 days
- Submission Type
- Summary