FDA 510(k)

EPI-K

K-Number: K043183 · 2005-03-25

Decision Date2005-03-25

Product CodeHNO

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

EPI-K is the device name listed in this FDA 510(k) record. The listed applicant is Moria SA. It received FDA 510(k) clearance on 2005-03-25 under 510(k) number K043183. 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?

EPI-K is a medical device that received FDA 510(k) clearance on 2005-03-25. The listed applicant is Moria SA. The 510(k) number is K043183.

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

EPI-K received FDA 510(k) clearance on 2005-03-25, under 510(k) number K043183.

Who is the listed applicant for EPI-K?

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?

The FDA product code for EPI-K is HNO.

Other records listing Moria SA as applicant

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.

K172994EPI K Console K032836M3 MICROKERATOME K040297ONEUSE- PLUS MICROKERATOME K022560M2 SINGLE USE MICROKERTOME

Related Devices (Code: HNO)

K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.K172994EPI K ConsoleMoria SA K072102EPIVISION SL SYSTEMGebauer Medizintechnik GmbH K082043CARRIAZO-PENDULAR MICROKERATOMESchwind Eye-Tech-Solutions GmbH & Co. KG K062465ZYOPTIX XP EPI SEPARATOR SYSTEMBausch & Lomb, Inc.K052891HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEMHawken Industries

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.