VISTA PLUS— 510(k) K042108

Substantially Equivalent

Novacor

FDA 510(k) clearance K042108 for VISTA PLUS, Substantially Equivalent on 2005-01-19. Applicant: Novacor. Device class: 2.

Clearance details

Applicant: Novacor
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2004-08-04
Decision date: 2005-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rueil Malmaison Cedex, FR

Download summary PDF View on FDA.gov ↗

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