HYPERION X9— 510(k) K123381

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K123381 for HYPERION X9, Substantially Equivalent on 2013-05-10. Applicant: Cefla S.C.. Device class: 2.

Clearance details

Applicant: Cefla S.C.
Product code: Product code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2012-11-01
Decision date: 2013-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ormond Beach, FL, 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.