R-TEST EVOLUTION 3— 510(k) K040753

Substantially Equivalent

Novacor

FDA 510(k) clearance K040753 for R-TEST EVOLUTION 3, Substantially Equivalent on 2004-06-10. 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: 2004-03-24
Decision date: 2004-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Rueil Malmaison Cedex, FR

Download summary PDF View on FDA.gov ↗

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