Cleared Traditional

NFANT Feeding Solution

K143507 · Nfant Labs, LLC · Neurology
Sep 2015
Decision
273d
Days
Class 2
Risk

About This 510(k) Submission

K143507 is an FDA 510(k) clearance for the NFANT Feeding Solution, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Nfant Labs, LLC (Atlanta, US). The FDA issued a Cleared decision on September 9, 2015, 273 days after receiving the submission on December 10, 2014. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K143507 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2014
Decision Date September 09, 2015
Days to Decision 273 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