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FDA 510(k)

EPI K Console

K-Number: K172994 · 2017-10-26

ApplicantMoria SA
Decision Date2017-10-26
Product CodeHNO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EPI K Console is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2017-10-26 under 510(k) number K172994. The device is classified under product code HNO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPI K Console?

EPI K Console is a medical device that received FDA 510(k) clearance on 2017-10-26. The listed applicant is Moria SA. The 510(k) number is K172994.

When did EPI K Console receive FDA 510(k) clearance?

EPI K Console received FDA 510(k) clearance on 2017-10-26, under 510(k) number K172994.

Who is the listed applicant for EPI K Console?

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

What is the FDA product code for EPI K Console?

The FDA product code for EPI K Console is HNO.

Related Devices (Code: HNO)

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.

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.

Official Source

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

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