K-number	K803225
Device name	ADVANCEMED EXAMINER
Applicant	American Edwards Laboratories
Product code	DSF
Device class	Class I
Decision date	Jan 13, 1981
Decision	Substantially Equivalent
Regulation	870.2810

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Source

View the full FDA submission: accessdata.fda.gov

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ADVANCEMED EXAMINER

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