510(k) K100160 ยท MYB Pillow, Cervical (For Mild Sleep Apnea)
ZZOMA POSITIONAL SLEEPER MODEL 001
| Applicant | Sleep Specialists, LLC, Greenville DE, US |
| Decision | Substantially Equivalent, May 11, 2010 |
| Received | Jan 20, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100160
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.