Anesthesiology
Review Panel
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- ChemistryReview Panel
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- Gastroenterology and UrologyReview Panel
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- Cardiovascular Diagnostic DevicesCFR Sub-Part
- Cardiovascular Monitoring DevicesCFR Sub-Part
- Cardiovascular Therapeutic DevicesCFR Sub-Part
- Diagnostic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- LEMHuman Lyophilized Dura Mater2Product Code
- LGWStimulator, Spinal-Cord, Totally Implanted For Pain Relief3Product Code
- LHYElectrode, Stabilized Epidural Spinal3Product Code
- LIIMonitor, Intracranial Pressure, Implanted3Product Code
- LKWLaser, Neurosurgical3Product Code
- LLEStimulator, Spinal-Cord, Implanted For Peripheral Vascular Disease3Product Code
- LLFLaser, Neurosurgical, Argon3Product Code
- LLPLaser For Pain Therapy3Product Code
- LMEMonitor, Blood-Flow, Cerebral, Thermal Diffusion3Product Code
- LQDRecorder, Attention Task PerformanceUProduct Code
- LYIStimulator, Subcortical, Implanted For Epilepsy3Product Code
- LYJStimulator, Autonomic Nerve, Implanted For Epilepsy3Product Code
- MBXStimulator, Thalamic, Epilepsy, Implanted3Product Code
- BWKStimulator, Electro-AcupunctureUProduct Code
- KGFAdhesive, Tissue For Aneurysmorrhaphy3Product Code
- QCFNeuromuscular Tongue Stimulator To Treat Motor Deficits2Product Code
- KGGTissue Adhesive For Use In Embolization Of Brain Arteriovenous Malformations3Product Code
- LBKDevice, Neurosurgical Fragmentation And AspirationUProduct Code
- QMZDigital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions2Product Code
- QPFPediatric Autism Spectrum Disorder Diagnosis Aid2Product Code
- QQCBrain Stimulation Programming Planning Software.2Product Code
- QFTDigital Therapeutic Software For Attention Deficit Hyperactivity Disorder2Product Code
- MFEAgent, Injectable, Embolic3Product Code
- MFRStimulator, Brain, Implanted, For Behavior ModificationFProduct Code
- MHYStimulator, Electrical, Implanted, For Parkinsonian Tremor3Product Code
- MHZStimulator, Vestibular Acceleration, Therapeutic3Product Code
- MKDStimulator, Functional Walking Neuromuscular, Non-Invasive3Product Code
- MLQInhibitor, Peridural Fibrosis (Adhesion Barrier)3Product Code
- MRUImplanted Subcortical Electrical Stimulator (Motor Disorders)FProduct Code
- MUZStimulator, Autonomic Nerve, Implanted (Depression)3Product Code
- MVVDevice, AcupressureUProduct Code
- MXMCap, Cooling (Infants)3Product Code
- NHLStimulator, Electrical, Implanted, For Parkinsonian Symptoms3Product Code
- NJEIntracranial Neurovascular StentFProduct Code
- NPEMaterial, Embolization, Neurovascular, Polymerizing Or Precipitating3Product Code
- NQRSealant, Dural3Product Code
- NZKStimulator, Low Electric Field, Tumor Treatment3Product Code
- OBAPolymerizing, Neurovascular Embolization MaterialFProduct Code
- OLMDeep Brain Stimulator For Obsessive Compulsive Disorder (Ocd)FProduct Code
- OPRIntrasaccular Flow Disruption Device3Product Code
- OUTIntracranial Aneurysm Flow Diverter3Product Code
- OUUPolymeric Neurovascular EmbolizationFProduct Code
- OVCHeadframeNProduct Code
- OZJInhibitor, Postoperative Fibrosis (Adhesion Barrier)NProduct Code
- PAXSurgical KitFProduct Code
- PCQInhibitor, Postoperative Fibrosis (Spine Adhesion Barrier)NProduct Code
- PFNImplanted Brain Stimulator For Epilepsy3Product Code
- PJSStimulator, Electrical, Implanted, For Essential Tremor3Product Code
- PMPDorsal Root Ganglion Stimulator For Pain Relief3Product Code
- POHMr-Guided Focused Ultrasound System3Product Code
- QCAIntracranial Coil-Assist Stent3Product Code
- QLKStimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief3Product Code
- QRBStimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy3Product Code
- QSLBrain Temperature Measurement System2Product Code
- QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms2Product Code
- Submissions with No Product CodeMiscellaneous
- Neurological Diagnostic DevicesCFR Sub-Part
- Neurological Surgical DevicesCFR Sub-Part
- Neurological Therapeutic DevicesCFR Sub-Part
- Physical Medicine Diagnostic DevicesCFR Sub-Part
- Physical Medicine Prosthetic DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
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NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- DEN200033
- 510(k) Type
- Direct
- Applicant
- NightWare, Inc
- Country
- United States
- FDA Decision
- Deleted
- Decision Date
- 11/6/2020
- Days to Decision
- 163 days