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FDA 510(k)

IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO

K-Number: K101813 · 2010-10-05

ApplicantImris, Inc.
Decision Date2010-10-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO is the device name listed in this FDA 510(k) record. The listed applicant is Imris, Inc.. It received FDA 510(k) clearance on 2010-10-05 under 510(k) number K101813. 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 SYSTEM V1 AND IMRISNV/IMRISCARDIO?

IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO is a medical device that received FDA 510(k) clearance on 2010-10-05. The listed applicant is Imris, Inc.. The 510(k) number is K101813.

When did IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO receive FDA 510(k) clearance?

IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO received FDA 510(k) clearance on 2010-10-05, under 510(k) number K101813.

Who is the listed applicant for IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO?

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 SYSTEM V1 AND IMRISNV/IMRISCARDIO?

The FDA product code for IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO 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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