K-number	K052804
Device name	BREATHKEY MODEL G10/BREATHKEY MODEL G30X
Applicant	Omega Point Systems, LLC
Product code	DJZ
Device class	Class I
Decision date	Dec 9, 2005
Decision	Substantially Equivalent
Regulation	862.3050

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Source

View the full FDA submission: accessdata.fda.gov

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BREATHKEY MODEL G10/BREATHKEY MODEL G30X

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