K-number	K003787
Device name	NEWTOM QR-DVT 9000
Applicant	Aperio Services, LLC
Product code	OAS
Device class	Class II
Decision date	Mar 8, 2001
Decision	Substantially Equivalent
Regulation	892.1750

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View the full FDA submission: accessdata.fda.gov

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NEWTOM QR-DVT 9000

Everything you need for a 510(k) submission. Nothing you don't.