Name: Predicase
Price: 199 USD

K-number	K110168
Device name	ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE
Applicant	Zoll Medical Corporation, World Wide Headquarters
Product code	MKJ
Device class	Class III
Decision date	Feb 17, 2011
Decision	Substantially Equivalent
Regulation	870.5310

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Source

View the full FDA submission: accessdata.fda.gov

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ZOLL E SERIES WITH 2010 AHA GUIDLINES SOFTWARE UPDATE

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