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FDA 510(k)

Lunoa System

K-Number: K180608 · 2018-06-05

ApplicantNightbalance BV
Decision Date2018-06-05
Product CodeMYB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Lunoa System is a medical device manufactured by Nightbalance BV. It received FDA 510(k) clearance on 2018-06-05 under approval number K180608. The device is classified under product code MYB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lunoa System?

Lunoa System is a medical device that received FDA 510(k) clearance on 2018-06-05. It is manufactured by Nightbalance BV. The 510(k) number is K180608.

When was Lunoa System approved by the FDA?

Lunoa System received FDA 510(k) clearance on 2018-06-05, under approval number K180608.

What company makes Lunoa System?

Lunoa System is manufactured by Nightbalance BV.

What is the FDA product code for Lunoa System?

The FDA product code for Lunoa System is MYB.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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