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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 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.

Related Clinical Trials

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Related Devices (Code: MYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100160ZZOMA POSITIONAL SLEEPER MODEL 001Sleep Specialists, LLCK040161SONA PILLOWSleep Devices, Inc.K023010SNIFF POSITION PILLOWS/POPITZ PILLOWSAeolus International CorporationK990871PILLOWPOSITIVE CERVICAL PILLOWLifesleep Systems, Inc.

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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