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FDA 510(k)

HYPERION X5

K-Number: K161900 · 2016-12-09

ApplicantCefla S.C.
Decision Date2016-12-09
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HYPERION X5 is a medical device manufactured by Cefla S.C.. It received FDA 510(k) clearance on 2016-12-09 under approval number K161900. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERION X5?

HYPERION X5 is a medical device that received FDA 510(k) clearance on 2016-12-09. It is manufactured by Cefla S.C.. The 510(k) number is K161900.

When was HYPERION X5 approved by the FDA?

HYPERION X5 received FDA 510(k) clearance on 2016-12-09, under approval number K161900.

What company makes HYPERION X5?

HYPERION X5 is manufactured by Cefla S.C..

What is the FDA product code for HYPERION X5?

The FDA product code for HYPERION X5 is OAS.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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