Name: Predicase
Price: 199 USD

K-number	K063494
Device name	DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
Applicant	Pro-Med Instruments GmbH
Product code	HBL
Device class	Class II
Decision date	May 21, 2007
Decision	Substantially Equivalent
Regulation	882.4460

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Source

View the full FDA submission: accessdata.fda.gov

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DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS

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