Cleared Special

MODIFICATION TO: POCKETVIEW ECG SOFTWARE

K013311 · Micromedical Industries, Ltd. · Cardiovascular
Jan 2002
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K013311 is an FDA 510(k) clearance for the MODIFICATION TO: POCKETVIEW ECG SOFTWARE, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Micromedical Industries, Ltd. (Labrador, Queensland, AU). The FDA issued a Cleared decision on January 3, 2002, 91 days after receiving the submission on October 4, 2001. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K013311 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2001
Decision Date January 03, 2002
Days to Decision 91 days
Submission Type Special
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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