K-number	K101660
Device name	ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8
Applicant	Kepler Medtec
Product code	DSA
Device class	Class II
Decision date	Aug 11, 2010
Decision	Substantially Equivalent
Regulation	870.2900

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View the full FDA submission: accessdata.fda.gov

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ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8

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