Cleared Traditional

Carescape One

K190008 · Ge Healthcare · Cardiovascular
Dec 2019
Decision
352d
Days
Class 2
Risk

About This 510(k) Submission

K190008 is an FDA 510(k) clearance for the Carescape One, 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 December 20, 2019, 352 days after receiving the submission on January 2, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K190008 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 2019
Decision Date December 20, 2019
Days to Decision 352 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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