Cleared Traditional

Pacifier Activated Lullaby (PAL?)

K151050 · Power Medical Devices, LLC · Neurology
Dec 2015
Decision
246d
Days
Class 2
Risk

About This 510(k) Submission

K151050 is an FDA 510(k) clearance for the Pacifier Activated Lullaby (PAL?), a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Power Medical Devices, LLC (Delray Beach, US). The FDA issued a Cleared decision on December 22, 2015, 246 days after receiving the submission on April 20, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K151050 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2015
Decision Date December 22, 2015
Days to Decision 246 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCC — Device, Biofeedback
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5050