Cleared Traditional

MultiStim ECO

K162086 · PAJUNK GmbH Medizintechnologie · Anesthesiology
Jan 2017
Decision
163d
Days
Class 2
Risk

About This 510(k) Submission

K162086 is an FDA 510(k) clearance for the MultiStim ECO, a Stimulator, Nerve, Battery-powered (Class II — Special Controls, product code BXN), submitted by PAJUNK GmbH Medizintechnologie (Geisingen, DE). The FDA issued a Cleared decision on January 6, 2017, 163 days after receiving the submission on July 27, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number K162086 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2016
Decision Date January 06, 2017
Days to Decision 163 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BXN — Stimulator, Nerve, Battery-powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2775

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