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Electromyograph, Diagnostic

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.1375
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.1375 Diagnostic electromyograph

§ 890.1375 Diagnostic electromyograph.

(a) Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

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

Electromyograph, Diagnostic

Page Type
Product Code
Regulation Medical Specialty
Physical Medicine
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
890.1375
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 890.1375 Diagnostic electromyograph

§ 890.1375 Diagnostic electromyograph.

(a) Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.

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