510(k) K151050 · HCC Device, Biofeedback
Pacifier Activated Lullaby (PAL®)
| Applicant | Power Medical Devices, LLC, Delray Beach FL, US |
| Decision | Substantially Equivalent, Dec 22, 2015 |
| Received | Apr 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151050
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 1, 2015 | Powers Medical Devices, LLC The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed t Open, Classified |
HCC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.