Cleared Traditional

GrindCare System

K163448 · Sunstar Suisse S.A. · Neurology
Sep 2017
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K163448 is an FDA 510(k) clearance for the GrindCare System, a Device, Biofeedback (Class II — Special Controls, product code HCC), submitted by Sunstar Suisse S.A. (Etoy, CH). The FDA issued a Cleared decision on September 1, 2017, 267 days after receiving the submission on December 8, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5050.

Submission Details

510(k) Number K163448 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2016
Decision Date September 01, 2017
Days to Decision 267 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