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Electrode, Needle

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1350
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1350 Needle electrode

§ 882.1350 Needle electrode.

(a) Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

(b) Classification. Class II (performance standards).

Electrode, Needle

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1350
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1350 Needle electrode

§ 882.1350 Needle electrode.

(a) Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

(b) Classification. Class II (performance standards).