PROXIS SYSTEM, MODEL EPS101— 510(k) K060651

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K060651 for PROXIS SYSTEM, MODEL EPS101, Substantially Equivalent on 2006-09-13. Applicant: St Jude Medical. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code NFA
Device class: Class 2
Regulation: 21 CFR 870.1250
Advisory panel: Cardiovascular
Date received: 2006-03-13
Decision date: 2006-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.