K-number	K053369
Device name	MEDILOG DARWIN HOLTER ANALYSIS
Applicant	Huntleigh Healthcare
Product code	DQK
Device class	Class II
Decision date	Dec 22, 2005
Decision	Substantially Equivalent
Regulation	870.1425

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View the full FDA submission: accessdata.fda.gov

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MEDILOG DARWIN HOLTER ANALYSIS

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