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FDA 510(k)

NIM 3.0

K-Number: K083124 · 2009-02-27

ApplicantMedtronic Xomed, Inc.
Decision Date2009-02-27
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NIM 3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K083124. 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 NIM 3.0?

NIM 3.0 is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K083124.

When did NIM 3.0 receive FDA 510(k) clearance?

NIM 3.0 received FDA 510(k) clearance on 2009-02-27, under 510(k) number K083124.

Who is the listed applicant for NIM 3.0?

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

What is the FDA product code for NIM 3.0?

The FDA product code for NIM 3.0 is GWF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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