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Evoked Potential Stimulator, Thermal

Page Type
Product Code
Definition
Intended to evaluate the functionality of human pain reception and transmission of sensory pathways
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1870
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1870 Evoked response electrical stimulator

§ 882.1870 Evoked response electrical stimulator.

(a) Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

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

Evoked Potential Stimulator, Thermal

Page Type
Product Code
Definition
Intended to evaluate the functionality of human pain reception and transmission of sensory pathways
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1870
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 882.1870 Evoked response electrical stimulator

§ 882.1870 Evoked response electrical stimulator.

(a) Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

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