The following data is part of a premarket notification filed by Nightbalance Bv with the FDA for Lunoa System.
| Device ID | K180608 |
| 510k Number | K180608 |
| Device Name: | Lunoa System |
| Classification | Pillow, Cervical (for Mild Sleep Apnea) |
| Applicant | NightBalance BV Benoordenhoustseweg 46-13 Den Haag, NL |
| Contact | Sophia Lam |
| Correspondent | Cindy Domecus, R.a.c. (us & Eu) Domecus Consulting Services LLC 1171 Barroilhet Drive Hilsborough, CA 94010 |
| Product Code | MYB |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-07 |
| Decision Date | 2018-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959058743 | K180608 | 000 |
| 30606959059598 | K180608 | 000 |
| 30606959059581 | K180608 | 000 |
| 30606959057518 | K180608 | 000 |
| 30606959054630 | K180608 | 000 |
| 30606959054616 | K180608 | 000 |
| 08719689344030 | K180608 | 000 |
| 08719689344092 | K180608 | 000 |
| 00606959054639 | K180608 | 000 |