ELTRAC 471— 510(k) K151640

Substantially Equivalent

Enraf-Nonius, B.V.

FDA 510(k) clearance K151640 for ELTRAC 471, Substantially Equivalent on 2015-10-16. Applicant: Enraf-Nonius, B.V.. Device class: 2.

Clearance details

Applicant: Enraf-Nonius, B.V.
Product code: Code ITH
Device class: Class 2
Regulation: 21 CFR 890.5900
Advisory panel: Physical Medicine
Date received: 2015-06-18
Decision date: 2015-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rotterdam, NL

Download summary PDF View on FDA.gov ↗

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