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FDA 510(k)

IMRX

K-Number: K091166 · 2009-09-02

ApplicantImris, Inc.
Decision Date2009-09-02
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMRX is the device name listed in this FDA 510(k) record. The listed applicant is Imris, Inc.. It received FDA 510(k) clearance on 2009-09-02 under 510(k) number K091166. 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 IMRX?

IMRX is a medical device that received FDA 510(k) clearance on 2009-09-02. The listed applicant is Imris, Inc.. The 510(k) number is K091166.

When did IMRX receive FDA 510(k) clearance?

IMRX received FDA 510(k) clearance on 2009-09-02, under 510(k) number K091166.

Who is the listed applicant for IMRX?

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 IMRX?

The FDA product code for IMRX is LNH.

Other records listing Imris, Inc. as applicant

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Related Devices (Code: 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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