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FDA 510(k)

IDENTEVENT, VERSION 1.0G

K-Number: K092039 · 2009-10-16

ApplicantOptima Neuroscience, Inc.
Decision Date2009-10-16
Product CodeOMB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

IDENTEVENT, VERSION 1.0G is the device name listed in this FDA 510(k) record. The listed applicant is Optima Neuroscience, Inc.. It received FDA 510(k) clearance on 2009-10-16 under 510(k) number K092039. The device is classified under product code OMB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDENTEVENT, VERSION 1.0G?

IDENTEVENT, VERSION 1.0G is a medical device that received FDA 510(k) clearance on 2009-10-16. The listed applicant is Optima Neuroscience, Inc.. The 510(k) number is K092039.

When did IDENTEVENT, VERSION 1.0G receive FDA 510(k) clearance?

IDENTEVENT, VERSION 1.0G received FDA 510(k) clearance on 2009-10-16, under 510(k) number K092039.

Who is the listed applicant for IDENTEVENT, VERSION 1.0G?

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

What is the FDA product code for IDENTEVENT, VERSION 1.0G?

The FDA product code for IDENTEVENT, VERSION 1.0G is OMB.

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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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