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FDA 510(k)

NEUROEPG SYSTEM

K-Number: K123843 · 2013-06-05

ApplicantStrohl Medical Technologies
Decision Date2013-06-05
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROEPG SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Strohl Medical Technologies. It received FDA 510(k) clearance on 2013-06-05 under 510(k) number K123843. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROEPG SYSTEM?

NEUROEPG SYSTEM is a medical device that received FDA 510(k) clearance on 2013-06-05. The listed applicant is Strohl Medical Technologies. The 510(k) number is K123843.

When did NEUROEPG SYSTEM receive FDA 510(k) clearance?

NEUROEPG SYSTEM received FDA 510(k) clearance on 2013-06-05, under 510(k) number K123843.

Who is the listed applicant for NEUROEPG SYSTEM?

The FDA 510(k) record lists Strohl Medical Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROEPG SYSTEM?

The FDA product code for NEUROEPG SYSTEM is GWF.

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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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