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FDA 510(k)

FRONTIER DEVICES NEURO SYSTEM

K-Number: K100205 · 2010-12-13

ApplicantFolsom Metal Products, Inc.
Decision Date2010-12-13
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

FRONTIER DEVICES NEURO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Folsom Metal Products, Inc.. It received FDA 510(k) clearance on 2010-12-13 under 510(k) number K100205. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRONTIER DEVICES NEURO SYSTEM?

FRONTIER DEVICES NEURO SYSTEM is a medical device that received FDA 510(k) clearance on 2010-12-13. The listed applicant is Folsom Metal Products, Inc.. The 510(k) number is K100205.

When did FRONTIER DEVICES NEURO SYSTEM receive FDA 510(k) clearance?

FRONTIER DEVICES NEURO SYSTEM received FDA 510(k) clearance on 2010-12-13, under 510(k) number K100205.

Who is the listed applicant for FRONTIER DEVICES NEURO SYSTEM?

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

What is the FDA product code for FRONTIER DEVICES NEURO SYSTEM?

The FDA product code for FRONTIER DEVICES NEURO SYSTEM is GWO.

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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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