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FDA 510(k)

NEMA-ST, MODEL V1.0.2

K-Number: K100668 · 2010-12-08

ApplicantNervomatrix, Ltd.
Decision Date2010-12-08
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEMA-ST, MODEL V1.0.2 is the device name listed in this FDA 510(k) record. The listed applicant is Nervomatrix, Ltd.. It received FDA 510(k) clearance on 2010-12-08 under 510(k) number K100668. 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 NEMA-ST, MODEL V1.0.2?

NEMA-ST, MODEL V1.0.2 is a medical device that received FDA 510(k) clearance on 2010-12-08. The listed applicant is Nervomatrix, Ltd.. The 510(k) number is K100668.

When did NEMA-ST, MODEL V1.0.2 receive FDA 510(k) clearance?

NEMA-ST, MODEL V1.0.2 received FDA 510(k) clearance on 2010-12-08, under 510(k) number K100668.

Who is the listed applicant for NEMA-ST, MODEL V1.0.2?

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

What is the FDA product code for NEMA-ST, MODEL V1.0.2?

The FDA product code for NEMA-ST, MODEL V1.0.2 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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