Name: Predicase
Price: 199 USD

K-number	K183632
Device name	Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
Applicant	Baylis Medical Company, Inc.
Product code	DRF
Device class	Class II
Decision date	Jun 7, 2019
Decision	Substantially Equivalent
Regulation	870.1220

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Source

View the full FDA submission: accessdata.fda.gov

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Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable

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