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
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- IKNElectromyograph, Diagnostic2Product Code
- K172743Natus VikingQuest2Cleared 510(K)
- K163150ViMove22Cleared 510(K)
- K162383Cadwell Sierra Summit, Cadwell Sierra Ascent2Cleared 510(K)
- K142494ViMove2Cleared 510(K)
- K131094VIMOVE2Cleared 510(K)
- K123902PHYSICAL MONITORING REGISTRATION UNIT-S (PMRU-S)2Cleared 510(K)
- K123399MYOVISION 3.0 WIREFREE SYSTEM2Cleared 510(K)
- K113074CMAP PRO2Cleared 510(K)
- K102610FOCUS EMG DEVICE2Cleared 510(K)
- K110048CERSR ELECTROMYOGRAPHY SYSTEM2Cleared 510(K)
- K083679UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO12Cleared 510(K)
- K073415NEMUS SYSTEM; NEMUS PC PERIPHERAL2Cleared 510(K)
- K063447INSIGHT DISCOVERY2Cleared 510(K)
- K052112XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK10592Cleared 510(K)
- K031995COMPREHENSIVE NEUROMUSCULAR PROFILER2Cleared 510(K)
- K033452CWAS 10002Cleared 510(K)
- K023209INSIGHT MILLENNIUM III2Cleared 510(K)
- K024316NIM-PRS2Cleared 510(K)
- K023147ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-42Cleared 510(K)
- K022719PHYSICAL MONITORING REGISTRATION UNIT2Cleared 510(K)
- K010590NEUROPACK MICRO, MODEL MED-9100A SERIES2Cleared 510(K)
- K002104COMBINED PHYSIOLOGICAL MONITORING SYSTEM2Cleared 510(K)
- K001800ACCUWARM EMG HEAT LAMP2Cleared 510(K)
- K001562NEURO SCAN MEDICAL SYSTEMS A40002Cleared 510(K)
- K000812NEURO SCAN MEDICAL SYSTEMS, MODELS 302L MEDICOR (LABORATORY) AND 302P ADVANTAGE 3000 (PORTABLE)2Cleared 510(K)
- K000220MA-300 ELECTROMYOGRAPHY SYSTEM2Cleared 510(K)
- K993878JE 20002Cleared 510(K)
- K990766CERSR ELECTROMYOGRAPHY SYSTEM2Cleared 510(K)
- K984052SYNERGY IOM SYSTEM2Cleared 510(K)
- K972419TOENNIES NEUROSCREEN SYSTEM2Cleared 510(K)
- K974385MLS ELECTROMYOGRAPHIC PREAMPLIFIER2Cleared 510(K)
- K974010ADVANTAGE EMG SYSTEM, MODEL #A1002Cleared 510(K)
- K973355ADVANTAGE 30002Cleared 510(K)
- K941144EXCEL EMG2Cleared 510(K)
- K942965COMPUTER DYNO/GONIO/MYO GRAPHY2Cleared 510(K)
- K952655B & L ELECTRODE2Cleared 510(K)
- K944787INTEGRATED MOVEMENT ANALYZER2Cleared 510(K)
- K935368STC DIAGNOSTIC 80002Cleared 510(K)
- K930328NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT2Cleared 510(K)
- K922488PHASIS ELECTROMYOGRAPH2Cleared 510(K)
- K901732EMG ACCESSORY FOR POSTUROGRAPHY2Cleared 510(K)
- K893130EMG NAVIGATOR & EMG TRAVELER2Cleared 510(K)
- K883781NICOLET NEUROPORT/ACE SYSTEM2Cleared 510(K)
- K890495NICOLET VIKING II SYSTEM2Cleared 510(K)
- K880976AL-200B MUSCLE ACTIVITY INTEGRATOR2Cleared 510(K)
- K880977ADR-2000 AMBULATORY DATA RECORDING SYSTEM2Cleared 510(K)
- K880573MODIFIED NICOLET VIKING SYSTEM2Cleared 510(K)
- K872836SPINOSCOPE2Cleared 510(K)
- K864660MODEL M402 EMG MONITOR2Cleared 510(K)
- K864408EMG-1, MOTOR NERVE MONITOR2Cleared 510(K)
- K864641VENTEX-IA2Cleared 510(K)
- K864630KC/EMG DIAGNOSTIC ELECTROMYOGRAPH2Cleared 510(K)
- K862236MYOLAB II, MODEL ML-2002Cleared 510(K)
- K853804VICON (MODIFICATION)2Cleared 510(K)
- K842649BATH TUB TRANSFER CHAIR2Cleared 510(K)
- K842956NICOLET VIKING2Cleared 510(K)
- K842613COMPACT VISUAL2Cleared 510(K)
- K842612COMPACT AUDITORY2Cleared 510(K)
- K842611CA20002Cleared 510(K)
- K833927ELECTRO-MYOSCOPE 852Cleared 510(K)
- K830702NICOLET EMG SATELLITE2Cleared 510(K)
- K823562EMG MODULES FOR POLYGRAPH SYSTEM2Cleared 510(K)
- K822624O.T.E. BIOMEDICA B.A.S.I.S. MODEL 23812Cleared 510(K)
- K821910ANESTHESIA & BRAIN MONITOR2Cleared 510(K)
- K821237NEUROMATIC 20002Cleared 510(K)
- K812715TECA #TE 82Cleared 510(K)
- K802637TECA MODEL-10 ELECTROMYOGRAPH2Cleared 510(K)
- K800648CADWELL 72002Cleared 510(K)
- K791235CADWELL 7000 ELECTROMYOGRAPH MACHINE2Cleared 510(K)
- K790664MODEL 1309 AUDIO MONITOR2Cleared 510(K)
- K781399TECA MODEL B9 ELECTROMYOGRAPH2Cleared 510(K)
- K780541PRESSURE MODULES MODELS 1855 & 18562Cleared 510(K)
- K772005MYOTONE EMG MONITOR2Cleared 510(K)
- IKTElectrode, Needle, Diagnostic Electromyograph2Product Code
- LYHArthrometer1Product Code
- 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
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K083679
- 510(k) Type
- Traditional
- Applicant
- UROVAL
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/11/2009
- Days to Decision
- 274 days
- Submission Type
- Summary