Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device non-invasive evoked response brain stimulator
Definition A non-invasive evoked response brain stimulator is a non-penetrating device used to apply a stimulus to the brain for the purpose of measuring the evoked brain activity response.
Physical State Contains stimulation hardware (e.g., electrical, magnetic, etc.), recording hardware (e.g., electrodes, external storage device, wireless hardware, etc.), and software (e.g., used to process, analyze, display, store, or archive data).
Technical Method A device that delivers a controlled, non-invasive stimulation to the brain and records the brain activity in response to the stimuli.
Target Area Brain
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeSFN
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.1860
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-