Last synced on 25 November 2022 at 11:04 pm

Stimulator, Nerve

Page Type
Product Code
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
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

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.

Stimulator, Nerve

Page Type
Product Code
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
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

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.