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FDA 510(k)

NEURO III-SV

K-Number: K083137 · 2008-12-16

ApplicantImris, Inc.
Decision Date2008-12-16
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEURO III-SV is the device name listed in this FDA 510(k) record. The listed applicant is Imris, Inc.. It received FDA 510(k) clearance on 2008-12-16 under 510(k) number K083137. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEURO III-SV?

NEURO III-SV is a medical device that received FDA 510(k) clearance on 2008-12-16. The listed applicant is Imris, Inc.. The 510(k) number is K083137.

When did NEURO III-SV receive FDA 510(k) clearance?

NEURO III-SV received FDA 510(k) clearance on 2008-12-16, under 510(k) number K083137.

Who is the listed applicant for NEURO III-SV?

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

What is the FDA product code for NEURO III-SV?

The FDA product code for NEURO III-SV is LNH.

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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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