FDA 510(k)

OPTIMA MR 430S

K-Number: K123068 · 2012-11-13

Decision Date2012-11-13

Product CodeLNH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OPTIMA MR 430S is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2012-11-13 under 510(k) number K123068. 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 OPTIMA MR 430S?

OPTIMA MR 430S is a medical device that received FDA 510(k) clearance on 2012-11-13. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K123068.

When did OPTIMA MR 430S receive FDA 510(k) clearance?

OPTIMA MR 430S received FDA 510(k) clearance on 2012-11-13, under 510(k) number K123068.

Who is the listed applicant for OPTIMA MR 430S?

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

What is the FDA product code for OPTIMA MR 430S?

The FDA product code for OPTIMA MR 430S 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.