Cleared Special

CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES

K200494 · Ge Healthcare · Cardiovascular
Mar 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K200494 is an FDA 510(k) clearance for the CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Ge Healthcare (Milwaukee, US). The FDA issued a Cleared decision on March 29, 2020, 30 days after receiving the submission on February 28, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K200494 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2020
Decision Date March 29, 2020
Days to Decision 30 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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