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FDA 510(k)

MAMMODIAGNOST VU

K-Number: K083740 · 2009-02-13

ApplicantPhilips Medical Systems Nederland B.V.
Decision Date2009-02-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMODIAGNOST VU is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2009-02-13 under 510(k) number K083740. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMODIAGNOST VU?

MAMMODIAGNOST VU is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K083740.

When did MAMMODIAGNOST VU receive FDA 510(k) clearance?

MAMMODIAGNOST VU received FDA 510(k) clearance on 2009-02-13, under 510(k) number K083740.

Who is the listed applicant for MAMMODIAGNOST VU?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMODIAGNOST VU?

The FDA product code for MAMMODIAGNOST VU is LLZ.

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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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