K-number	K050320
Device name	FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT
Applicant	Ascendia Medtech AB
Product code	ITX
Device class	Class II
Decision date	Aug 15, 2005
Decision	Substantially Equivalent
Regulation	892.1570

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Source

View the full FDA submission: accessdata.fda.gov

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FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT

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