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Tester, Electrode/Lead, Electroencephalograph

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.1410
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1410 Electroencephalograph electrode/lead tester

§ 882.1410 Electroencephalograph electrode/lead tester.

(a) Identification. An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001]

Tester, Electrode/Lead, Electroencephalograph

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.1410
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1410 Electroencephalograph electrode/lead tester

§ 882.1410 Electroencephalograph electrode/lead tester.

(a) Identification. An electroencephalograph electrode/lead tester is a device used for testing the impedance (resistance to alternating current) of the electrode and lead system of an electroencephalograph to assure that an adequate contact is made between the electrode and the skin.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, 2001]