Cleared Abbreviated

VIEWPOINT TELEMETRY SYSTEM

K031760 · Datascope Corp. · Cardiovascular
Oct 2003
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K031760 is an FDA 510(k) clearance for the VIEWPOINT TELEMETRY SYSTEM, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Datascope Corp. (Mahwah, US). The FDA issued a Cleared decision on October 10, 2003, 126 days after receiving the submission on June 6, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K031760 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 2003
Decision Date October 10, 2003
Days to Decision 126 days
Submission Type Abbreviated
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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