Cleared Traditional

ANSISTIM

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

About This 510(k) Submission

K141168 is an FDA 510(k) clearance for the ANSISTIM, 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 review panel.

Submission Details

510(k) Number K141168 FDA.gov
FDA Decision Cleared 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 —

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