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FDA 510(k)

BIOGRAPH MMR

K-Number: K103429 · 2011-06-08

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2011-06-08
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BIOGRAPH MMR is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2011-06-08 under 510(k) number K103429. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOGRAPH MMR?

BIOGRAPH MMR is a medical device that received FDA 510(k) clearance on 2011-06-08. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K103429.

When did BIOGRAPH MMR receive FDA 510(k) clearance?

BIOGRAPH MMR received FDA 510(k) clearance on 2011-06-08, under 510(k) number K103429.

Who is the listed applicant for BIOGRAPH MMR?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOGRAPH MMR?

The FDA product code for BIOGRAPH MMR is OUO.

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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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