FDA 510(k)

OLYMPUS ENERGY POWER SYSTEM (EPS)

K-Number: K123429 · 2013-04-05

Decision Date2013-04-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OLYMPUS ENERGY POWER SYSTEM (EPS) is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K123429. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS ENERGY POWER SYSTEM (EPS)?

OLYMPUS ENERGY POWER SYSTEM (EPS) is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K123429.

When did OLYMPUS ENERGY POWER SYSTEM (EPS) receive FDA 510(k) clearance?

OLYMPUS ENERGY POWER SYSTEM (EPS) received FDA 510(k) clearance on 2013-04-05, under 510(k) number K123429.

Who is the listed applicant for OLYMPUS ENERGY POWER SYSTEM (EPS)?

The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS ENERGY POWER SYSTEM (EPS)?

The FDA product code for OLYMPUS ENERGY POWER SYSTEM (EPS) is GEI.

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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.