FDA 510(k)

PHILIPS HERCEPTEST DIGITAL SCORE

K-Number: K130021 · 2013-09-19

ApplicantPhilips Medical Systems Nederland B.V.

Decision Date2013-09-19

Product CodeOEO

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

PHILIPS HERCEPTEST DIGITAL SCORE 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 2013-09-19 under 510(k) number K130021. The device is classified under product code OEO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS HERCEPTEST DIGITAL SCORE?

PHILIPS HERCEPTEST DIGITAL SCORE is a medical device that received FDA 510(k) clearance on 2013-09-19. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K130021.

When did PHILIPS HERCEPTEST DIGITAL SCORE receive FDA 510(k) clearance?

PHILIPS HERCEPTEST DIGITAL SCORE received FDA 510(k) clearance on 2013-09-19, under 510(k) number K130021.

Who is the listed applicant for PHILIPS HERCEPTEST DIGITAL SCORE?

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 PHILIPS HERCEPTEST DIGITAL SCORE?

The FDA product code for PHILIPS HERCEPTEST DIGITAL SCORE is OEO.

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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.