K-number	K941937
Device name	PIKOS E 01-B
Applicant	Biotronik, Inc.
Product code	DXY
Device class	Class III
Decision date	Aug 30, 1994
Decision	Substantially Equivalent — with Special Conditions
Regulation	870.3610

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View the full FDA submission: accessdata.fda.gov

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PIKOS E 01-B

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