Cleared Traditional

MENNTOR X7

K141441 · Mennen Medical , Ltd. · Cardiovascular
Jan 2015
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K141441 is an FDA 510(k) clearance for the MENNTOR X7, a Detector And Alarm, Arrhythmia (Class II — Special Controls, product code DSI), submitted by Mennen Medical , Ltd. (Yavne, IL). The FDA issued a Cleared decision on January 9, 2015, 221 days after receiving the submission on June 2, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K141441 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2014
Decision Date January 09, 2015
Days to Decision 221 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSI — Detector And Alarm, Arrhythmia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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