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 the device name listed in this FDA 510(k) record. The listed applicant is Nightbalance BV. It received FDA 510(k) clearance on 2018-06-05 under 510(k) 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. The listed applicant is Nightbalance BV. The 510(k) number is K180608.
When did Lunoa System receive FDA 510(k) clearance?
Lunoa System received FDA 510(k) clearance on 2018-06-05, under 510(k) number K180608.
Who is the listed applicant for Lunoa System?
The FDA 510(k) record lists Nightbalance BV as the applicant. This does not by itself establish the device manufacturer.
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.