Cleared Traditional

BIOHARNESS

K100040 · Zephyr Technology Corporation · Cardiovascular
Dec 2010
Decision
330d
Days
Class 2
Risk

About This 510(k) Submission

K100040 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 (Annapolis, US). The FDA issued a Cleared decision on December 3, 2010, 330 days after receiving the submission on January 7, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K100040 FDA.gov
FDA Decision Cleared SESE
Date Received January 07, 2010
Decision Date December 03, 2010
Days to Decision 330 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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