Cleared Traditional

K141168 - ANSISTIM (FDA 510(k) Clearance)

K141168 · Dyansys, Inc. · Neurology device
May 2015
Decision
374d
Days
-
Risk

K141168 is an FDA 510(k) clearance for the ANSISTIM. This device is classified as a Stimulator, Electro-acupuncture.

Submitted by Dyansys, Inc. (San Mateo, US). The FDA issued a Cleared decision on May 15, 2015, 374 days after receiving the submission on May 6, 2014.

This device falls under the Neurology FDA review panel.

Submission Details

510(k) Number K141168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2014
Decision Date May 15, 2015
Days to Decision 374 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code BWK - Stimulator, Electro-acupuncture
Device Class -