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FDA 510(k)

MODIFICATION TO FMRI HARDWARE SYSTEM

K-Number: K092253 · 2009-10-08

ApplicantNordicneurolab
Decision Date2009-10-08
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO FMRI HARDWARE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Nordicneurolab. It received FDA 510(k) clearance on 2009-10-08 under 510(k) number K092253. 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 MODIFICATION TO FMRI HARDWARE SYSTEM?

MODIFICATION TO FMRI HARDWARE SYSTEM is a medical device that received FDA 510(k) clearance on 2009-10-08. The listed applicant is Nordicneurolab. The 510(k) number is K092253.

When did MODIFICATION TO FMRI HARDWARE SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO FMRI HARDWARE SYSTEM received FDA 510(k) clearance on 2009-10-08, under 510(k) number K092253.

Who is the listed applicant for MODIFICATION TO FMRI HARDWARE SYSTEM?

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

What is the FDA product code for MODIFICATION TO FMRI HARDWARE SYSTEM?

The FDA product code for MODIFICATION TO FMRI HARDWARE SYSTEM is LNH.

Related Clinical Trials

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Other records listing Nordicneurolab as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123306NORDIC TUMOREXK080515FMRI HARDWARE SYSTEMK073099FMRI HARDWARE SYSTEM

Related Devices (Code: LNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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