Cleared Traditional

MYSENSE HEART

K113176 · Cardiac Science Corporation · Cardiovascular
Dec 2011
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K113176 is an FDA 510(k) clearance for the MYSENSE HEART, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Cardiac Science Corporation (Bothell, US). The FDA issued a Cleared decision on December 21, 2011, 54 days after receiving the submission on October 28, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K113176 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2011
Decision Date December 21, 2011
Days to Decision 54 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800