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- 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
- 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
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Optical Neurosurgical Nerve Locator
- Page Type
- Product Code
- Definition
- To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.
- Physical State
- A user interface/control unit; and handpiece unit with a light source and an optical sensor.
- Technical Method
- Emits white light, collects information on the color reflected, and informs users of changes from baseline.
- Target Area
- Spinal nerve roots or peripheral nerves
- Regulation Medical Specialty
- Ear, Nose, Throat
- Review Panel
- Neurology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 874.1820
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 874.1820 Surgical nerve stimulator/locator
§ 874.1820 Surgical nerve stimulator/locator.
(a) Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.
(b) Classification. Class II.