K-number	K130021
Device name	PHILIPS HERCEPTEST DIGITAL SCORE
Applicant	Philips Medical Systems Nederland B.V.
Product code	OEO
Device class	Class II
Decision date	Sep 19, 2013
Decision	Substantially Equivalent
Regulation	864.1860

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Source

View the full FDA submission: accessdata.fda.gov

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PHILIPS HERCEPTEST DIGITAL SCORE

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