SIXALYZER— 510(k) K880230

Substantially Equivalent

Lukens Corp.

FDA 510(k) clearance K880230 for SIXALYZER, Substantially Equivalent on 1988-03-16. Applicant: Lukens Corp.. Device class: 2.

Clearance details

Applicant: Lukens Corp.
Product code: Code IKK
Device class: Class 2
Regulation: 21 CFR 890.1925
Advisory panel: Physical Medicine
Date received: 1988-01-20
Decision date: 1988-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Republica De Mexico 11850, 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.