Cleared Traditional

BIOHARNESS

K113045 · Zephyr Technology Corporation · Cardiovascular
Aug 2012
Decision
306d
Days
Class 2
Risk

About This 510(k) Submission

K113045 is an FDA 510(k) clearance for the BIOHARNESS, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Zephyr Technology Corporation (Stamford, US). The FDA issued a Cleared decision on August 14, 2012, 306 days after receiving the submission on October 13, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K113045 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2011
Decision Date August 14, 2012
Days to Decision 306 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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