MODIFIED JELTRODE(TM) ELECTRODES DEEMED— 510(k) K884348

Substantially Equivalent

Henley Intl.

FDA 510(k) clearance K884348 for MODIFIED JELTRODE(TM) ELECTRODES DEEMED, Substantially Equivalent on 1988-12-15. Applicant: Henley Intl.. Device class: 2.

Clearance details

Applicant
Henley Intl.
Product code
Code GXY
Device class
Class 2
Regulation
21 CFR 882.1320
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Sugar Land, TX, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GXY

view all

More clearances from Henley Intl.

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.