HYPERION X5— 510(k) K161900

Substantially Equivalent

Cefla S.C.

FDA 510(k) clearance K161900 for HYPERION X5, Substantially Equivalent on 2016-12-09. 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: 2016-07-11
Decision date: 2016-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Imola, IT

Download summary PDF View on FDA.gov ↗

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