FDA 510(k) Premarket Notification K180608: Lunoa System

Submission Details & Decision

Normalized public record details for 510(k) notification K180608.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K180608

Applicant / Sponsor

Nightbalance BV

Device Name

Lunoa System

Product Code

MYB

Decision Date

2018-06-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Dental (DE)

Clearance Type

Traditional

Third Party Flag

Date Received

2018-03-07

Related Establishments / Registrations

RESPIRONICS INC. Registration: 2518422 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
ADVANCED BRAIN MONITORING, INC. Registration: 3004964738 View Registration
UNITRON GROUP BV Registration: 3008388260 View Registration
Sleep Specialists, LLC Registration: 3008812550 View Registration
ZHEJIANG E-COZY ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3017965926 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
TPI Custom Solutions Registration: 3023194188 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.