• 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 stimulator, electrical, evoked response
Regulation Description Evoked response electrical stimulator.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWF
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostics (DHT5A)
Submission Type 510(k)
Regulation Number 882.1870
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
-
-