OMEGA T200— 510(k) K870667

Substantially Equivalent

Henley Intl.

FDA 510(k) clearance K870667 for OMEGA T200, Substantially Equivalent on 1987-04-22. Applicant: Henley Intl.. Device class: 2.

Clearance details

Applicant: Henley Intl.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1987-02-19
Decision date: 1987-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, 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.