Stimulator, Mechanical, Evoked Response

Device Code: 3691

Product Code(s): GZP

Device Classification Information

• Device Type ID: 3691
• Device Name: Stimulator, Mechanical, Evoked Response
• Regulation Description: Evoked Response Mechanical Stimulator.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurodiagnostic And Neurosurgical Devices Branch (NDNB)
• Submission Type: 510(k)
• CFR Regulation Number: 882.1880 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: GZP
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

• Device Type ID: 3691
• Device: Stimulator, Mechanical, Evoked Response
• Product Code: GZP
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Evoked Response Mechanical Stimulator.
• CFR Regulation Number: 882.1880 [🔎]

Device Problems
Temperature Problem	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 20:34:34