Lunoa System

Pillow, Cervical (for Mild Sleep Apnea)

NightBalance BV

The following data is part of a premarket notification filed by Nightbalance Bv with the FDA for Lunoa System.

Pre-market Notification Details

Device IDK180608
510k NumberK180608
Device Name:Lunoa System
ClassificationPillow, Cervical (for Mild Sleep Apnea)
Applicant NightBalance BV Benoordenhoustseweg 46-13 Den Haag,  NL
ContactSophia Lam
CorrespondentCindy Domecus, R.a.c. (us & Eu)
Domecus Consulting Services LLC 1171 Barroilhet Drive Hilsborough,  CA  94010
Product CodeMYB  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-07
Decision Date2018-06-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00606959058743 K180608 000
30606959059598 K180608 000
30606959059581 K180608 000
30606959057518 K180608 000
30606959054630 K180608 000
30606959054616 K180608 000
08719689344030 K180608 000
08719689344092 K180608 000

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