ENDOMED 582— 510(k) K922020

Substantially Equivalent

Henley Intl.

FDA 510(k) clearance K922020 for ENDOMED 582, Substantially Equivalent on 1992-09-22. Applicant: Henley Intl.. Device class: 2.

Clearance details

Applicant: Henley Intl.
Product code: Code LIH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1992-04-30
Decision date: 1992-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sugar Land, TX, US

Download summary PDF View on FDA.gov ↗

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