The following data is part of a premarket notification filed by Power Medical Devices, Llc with the FDA for Pacifier Activated Lullaby (pal®).
| Device ID | K151050 |
| 510k Number | K151050 |
| Device Name: | Pacifier Activated Lullaby (PAL®) |
| Classification | Device, Biofeedback |
| Applicant | Power Medical Devices, LLC 1615 S.Congress Ave, Ste 13 Delray Beach, FL 33445 |
| Contact | Patricia Palmer |
| Correspondent | Sharyn Orton MEDIcept, INC, 200 Homer Avenue Ashland, MA 01721 |
| Product Code | HCC |
| CFR Regulation Number | 882.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-12-22 |
| Summary: | summary |