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FDA 510(k)

BRIVO MR355, OPTIMA MR360

K-Number: K123417 · 2013-01-17

ApplicantGe Hangwei Medical Systems Co., Ltd.
Decision Date2013-01-17
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRIVO MR355, OPTIMA MR360 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. It received FDA 510(k) clearance on 2013-01-17 under 510(k) number K123417. 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 BRIVO MR355, OPTIMA MR360?

BRIVO MR355, OPTIMA MR360 is a medical device that received FDA 510(k) clearance on 2013-01-17. The listed applicant is Ge Hangwei Medical Systems Co., Ltd.. The 510(k) number is K123417.

When did BRIVO MR355, OPTIMA MR360 receive FDA 510(k) clearance?

BRIVO MR355, OPTIMA MR360 received FDA 510(k) clearance on 2013-01-17, under 510(k) number K123417.

Who is the listed applicant for BRIVO MR355, OPTIMA MR360?

The FDA 510(k) record lists Ge Hangwei Medical Systems Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRIVO MR355, OPTIMA MR360?

The FDA product code for BRIVO MR355, OPTIMA MR360 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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