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FDA 510(k)

MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE

K-Number: K121239 · 2012-05-24

ApplicantOptoacoustics, Ltd.
Decision Date2012-05-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE is the device name listed in this FDA 510(k) record. The listed applicant is Optoacoustics, Ltd.. It received FDA 510(k) clearance on 2012-05-24 under 510(k) number K121239. 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 MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE?

MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE is a medical device that received FDA 510(k) clearance on 2012-05-24. The listed applicant is Optoacoustics, Ltd.. The 510(k) number is K121239.

When did MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE receive FDA 510(k) clearance?

MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE received FDA 510(k) clearance on 2012-05-24, under 510(k) number K121239.

Who is the listed applicant for MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE?

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

What is the FDA product code for MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE?

The FDA product code for MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE is LNH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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