VARITEST— 510(k) K882547

Substantially Equivalent

Eureka AB

FDA 510(k) clearance K882547 for VARITEST, Substantially Equivalent on 1988-11-03. Applicant: Eureka AB. Device class: 2.

Clearance details

Applicant: Eureka AB
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 1988-06-21
Decision date: 1988-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, Sweden, SE

Download summary PDF View on FDA.gov ↗

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