Name: Predicase
Price: 199 USD

K-number	K965106
Device name	ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606
Applicant	Biotronik, Inc.
Product code	DTB
Device class	Class III
Decision date	Jan 27, 1998
Decision	Substantially Equivalent - Subject to Tracking & PMS
Regulation	870.3680

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Source

View the full FDA submission: accessdata.fda.gov

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ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

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