FDA · official record K161900Substantially Equivalent

HYPERION X5

Name: HYPERION X5 — FDA K161900
Creator: Cefla S.C.
Keywords: HYPERION X5, HYPERION X5, K161900, OAS, FDA

United StatesOASCefla S.C.

Verified

Official record identity

FDA application number: K161900
Decision date: December 09, 2016
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Cefla S.C.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2016-07-11
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.