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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 the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2016-12-09 under 510(k) 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. The listed applicant is Cefla S.C.. The 510(k) number is K161900.

When did HYPERION X5 receive FDA 510(k) clearance?

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

Who is the listed applicant for HYPERION X5?

The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERION X5?

The FDA product code for HYPERION X5 is OAS.

Other records listing Cefla S.C. as applicant

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Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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