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FDA 510(k)

PKS OMNI INSTRUMENT

K-Number: K081766 · 2008-08-08

ApplicantGyrus-Acmi L.P.
Decision Date2008-08-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PKS OMNI INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus-Acmi L.P.. It received FDA 510(k) clearance on 2008-08-08 under 510(k) number K081766. 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 PKS OMNI INSTRUMENT?

PKS OMNI INSTRUMENT is a medical device that received FDA 510(k) clearance on 2008-08-08. The listed applicant is Gyrus-Acmi L.P.. The 510(k) number is K081766.

When did PKS OMNI INSTRUMENT receive FDA 510(k) clearance?

PKS OMNI INSTRUMENT received FDA 510(k) clearance on 2008-08-08, under 510(k) number K081766.

Who is the listed applicant for PKS OMNI INSTRUMENT?

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

What is the FDA product code for PKS OMNI INSTRUMENT?

The FDA product code for PKS OMNI INSTRUMENT 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.

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