The following data is part of a premarket notification filed by Sleep Specialists, Llc with the FDA for Zzoma Positional Sleeper Model 001.
| Device ID | K100160 |
| 510k Number | K100160 |
| Device Name: | ZZOMA POSITIONAL SLEEPER MODEL 001 |
| Classification | Pillow, Cervical (for Mild Sleep Apnea) |
| Applicant | SLEEP SPECIALISTS, LLC 1 CONGRESSIONAL DRIVE APT C Greenville, DE 19807 |
| Contact | Howard Mann |
| Correspondent | Howard Mann SLEEP SPECIALISTS, LLC 1 CONGRESSIONAL DRIVE APT C Greenville, DE 19807 |
| Product Code | MYB |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-20 |
| Decision Date | 2010-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863826000315 | K100160 | 000 |