Lunoa System— 510(k) K180608

Substantially Equivalent

Nightbalance BV

FDA 510(k) clearance K180608 for Lunoa System, Substantially Equivalent on 2018-06-05. Applicant: Nightbalance BV. Device class: 2.

Clearance details

Applicant: Nightbalance BV
Product code: Code MYB
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 2018-03-07
Decision date: 2018-06-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Den Haag, 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.