Orfit Aerial Couchtop— 510(k) K200282

Substantially Equivalent

Orfit Industries NV

FDA 510(k) clearance K200282 for Orfit Aerial Couchtop, Substantially Equivalent on 2020-04-08. Applicant: Orfit Industries NV. Device class: 2.

Clearance details

Applicant: Orfit Industries NV
Product code: Code LHN
Device class: Class 2
Regulation: 21 CFR 892.5050
Advisory panel: Radiology
Date received: 2020-02-04
Decision date: 2020-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wijnegem, BE

Download summary PDF View on FDA.gov ↗

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