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FDA 510(k)

NEURO II-SE, MODELS: OR-DR-OR, OR-MB

K-Number: K071099 · 2007-05-22

ApplicantImris, Inc.
Decision Date2007-05-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NEURO II-SE, MODELS: OR-DR-OR, OR-MB is the device name listed in this FDA 510(k) record. The listed applicant is Imris, Inc.. It received FDA 510(k) clearance on 2007-05-22 under 510(k) number K071099. 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 II-SE, MODELS: OR-DR-OR, OR-MB?

NEURO II-SE, MODELS: OR-DR-OR, OR-MB is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Imris, Inc.. The 510(k) number is K071099.

When did NEURO II-SE, MODELS: OR-DR-OR, OR-MB receive FDA 510(k) clearance?

NEURO II-SE, MODELS: OR-DR-OR, OR-MB received FDA 510(k) clearance on 2007-05-22, under 510(k) number K071099.

Who is the listed applicant for NEURO II-SE, MODELS: OR-DR-OR, OR-MB?

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 II-SE, MODELS: OR-DR-OR, OR-MB?

The FDA product code for NEURO II-SE, MODELS: OR-DR-OR, OR-MB 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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