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FDA 510(k)

NEUROFLAX, EPK

K-Number: K831990 · 1983-11-28

ApplicantFranks Electronics
Decision Date1983-11-28
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROFLAX, EPK is the device name listed in this FDA 510(k) record. The listed applicant is Franks Electronics. It received FDA 510(k) clearance on 1983-11-28 under 510(k) number K831990. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROFLAX, EPK?

NEUROFLAX, EPK is a medical device that received FDA 510(k) clearance on 1983-11-28. The listed applicant is Franks Electronics. The 510(k) number is K831990.

When did NEUROFLAX, EPK receive FDA 510(k) clearance?

NEUROFLAX, EPK received FDA 510(k) clearance on 1983-11-28, under 510(k) number K831990.

Who is the listed applicant for NEUROFLAX, EPK?

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

What is the FDA product code for NEUROFLAX, EPK?

The FDA product code for NEUROFLAX, EPK is GZJ.

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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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