Anesthesiology
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- 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
- GWKConditioner, Signal, Physiological2Product Code
- GWLAmplifier, Physiological Signal2Product Code
- K242305BE Plus PRO, Neurotravel LIGHT2Cleared 510(K)
- K240646DreamClear2Cleared 510(K)
- K232210X-trodes System M2Cleared 510(K)
- K230148Vlab2Cleared 510(K)
- K223676SomniCheck2Cleared 510(K)
- K220631NomadAir PMU8102Cleared 510(K)
- K203331Quick-20m2Cleared 510(K)
- K202174Digital NeuroPort Biopotential Signal Processing System2Cleared 510(K)
- K2017478-CH Electroencephalography Amplifier2Cleared 510(K)
- K172312eego amplifiers2Cleared 510(K)
- K171397Sienna Ultimate Wireless Amplifier2Cleared 510(K)
- K171669g.Nautilus PRO2Cleared 510(K)
- K151600R-40 EEG Amplifier2Cleared 510(K)
- K133517NEMUS 2 SYSTEM2Cleared 510(K)
- K123255g.HIamp2Cleared 510(K)
- K121996BE PLUS LTM AMPLIFIER GWI AMPLIFIER2Cleared 510(K)
- K103140NICOLET WIRELESS EEG2Cleared 510(K)
- K092699NOMAD SLEEP SYSTEM RECORDER, MODEL PMU8002Cleared 510(K)
- K090957BLACKROCK NEUROPORT BIOPOTENTIAL SIGNAL PROCESSING SYSTEM2Cleared 510(K)
- K083322NEUROMETRIX BIOAMPLIFIER2Cleared 510(K)
- K063599PORTI 7 PHYSIOLOGICAL AMPLIFIER2Cleared 510(K)
- K060374REFA, PHYSIOLOGICAL AMPLIFIER2Cleared 510(K)
- K060803G.USBAMP2Cleared 510(K)
- K053606BE PLUS / AURA-LTM64 AMPLIFIER2Cleared 510(K)
- K051852SINGLE AMPLIFIER FOR BOTOX2Cleared 510(K)
- K052060OPTI-AMP DC-POWERED2Cleared 510(K)
- K041198NIC36 AMPLIFIER2Cleared 510(K)
- K040113SANDMAN SD20 AMPLIFIER2Cleared 510(K)
- K003154MIZAR, BASIS BE, SANDMAN DIGITAL2Cleared 510(K)
- K972515SENSOR AMPLIFIER2Cleared 510(K)
- K963669GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEM2Cleared 510(K)
- K943673MMC AMPLIFIER2Cleared 510(K)
- K914876OPTI-AMP2Cleared 510(K)
- K912436AM-PAK2Cleared 510(K)
- K901797THE WONDER BOX2Cleared 510(K)
- K904222VISTA GRAPH POLYSOMNOGRAPHY AMPLIFIER2Cleared 510(K)
- K900063MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)2Cleared 510(K)
- K884071AMPLAID EMG152Cleared 510(K)
- K881177MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD2Cleared 510(K)
- K880773THE VENUS SYSTEM2Cleared 510(K)
- K870794MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER2Cleared 510(K)
- K871678NICOLET AMP 6R11 SYSTEM2Cleared 510(K)
- K860289PHD-36 PHYSIOLOGICAL SIGNAL AMPLIFIER2Cleared 510(K)
- K861014AMPLAID MK15 (EVOKED POTENTIAL SYSTEM)2Cleared 510(K)
- K841612NEUROPACK II 51002Cleared 510(K)
- K833413COMPUTERSCOPE CPS-ABR2Cleared 510(K)
- K821250METRACO EVOKED POTENTIAL SYSTEM2Cleared 510(K)
- K781743RESPONSE SYSTEM, TN-30002Cleared 510(K)
- K781289PREAMPLIFIER MODEL 1132Cleared 510(K)
- K772102AMPLIFIER OTRONA, MODEL N3A-EMG2Cleared 510(K)
- K771683AMPLIFIER MODEL N3B-EEG2Cleared 510(K)
- 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
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- UnknownReview Panel
Sienna Ultimate Wireless Amplifier
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K171397
- 510(k) Type
- Traditional
- Applicant
- EMS Handels Gesellschaft m.b.H.
- Country
- Austria
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/6/2017
- Days to Decision
- 148 days
- Submission Type
- Summary