Cleared Abbreviated

SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX

K031849 · Datascope Corp. · Cardiovascular
Sep 2003
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K031849 is an FDA 510(k) clearance for the SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX, 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 September 9, 2003, 85 days after receiving the submission on June 16, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K031849 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2003
Decision Date September 09, 2003
Days to Decision 85 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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