Cleared Traditional

STIMPOD NMS450 NERVE STIMULATOR

K102084 · Xavant Technology (Pty), Ltd. · Anesthesiology
Dec 2010
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K102084 is an FDA 510(k) clearance for the STIMPOD NMS450 NERVE STIMULATOR, a Stimulator, Nerve, Battery-powered (Class II — Special Controls, product code BXN), submitted by Xavant Technology (Pty), Ltd. (Pretoria, Gauteng, ZA). The FDA issued a Cleared decision on December 16, 2010, 143 days after receiving the submission on July 26, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number K102084 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2010
Decision Date December 16, 2010
Days to Decision 143 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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