21 CFR 882.1410 — Tester, Electrode/Lead, Electroencephalograph

Neurology (NE) · Part 882 Subpart B—Neurological Diagnostic Devices · § 882.1410

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.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
GYATester, Electrode/Lead, Electroencephalograph15
Innolitics

Panel 1

/
Ready

Predicate graph will load when search results are available.

Embedding visualization will load when search results are available.

PDF viewer will load when search results are available.

Loading panels...

Select an item from Submissions

Click any panel, subpart, regulation, product code, or device to see details here.

Section Matches

Results will appear here.

Product Code Matches

Results will appear here.

Special Control Matches

Results will appear here.

Loading collections...