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FDA 510(k)

EEGER4 MODEL 4.3

K-Number: K122879 · 2013-02-06

ApplicantEeg Software, LLC
Decision Date2013-02-06
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEGER4 MODEL 4.3 is the device name listed in this FDA 510(k) record. The listed applicant is Eeg Software, LLC. It received FDA 510(k) clearance on 2013-02-06 under 510(k) number K122879. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEGER4 MODEL 4.3?

EEGER4 MODEL 4.3 is a medical device that received FDA 510(k) clearance on 2013-02-06. The listed applicant is Eeg Software, LLC. The 510(k) number is K122879.

When did EEGER4 MODEL 4.3 receive FDA 510(k) clearance?

EEGER4 MODEL 4.3 received FDA 510(k) clearance on 2013-02-06, under 510(k) number K122879.

Who is the listed applicant for EEGER4 MODEL 4.3?

The FDA 510(k) record lists Eeg Software, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EEGER4 MODEL 4.3?

The FDA product code for EEGER4 MODEL 4.3 is HCC.

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Related Devices (Code: HCC)

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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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