Cleared Traditional

Patient Monitor (RespArray)

K240320 · Edan Instruments, Inc. · Cardiovascular
Jun 2024
Decision
147d
Days
Class 2
Risk

About This 510(k) Submission

K240320 is an FDA 510(k) clearance for the Patient Monitor (RespArray), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on June 28, 2024, 147 days after receiving the submission on February 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K240320 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2024
Decision Date June 28, 2024
Days to Decision 147 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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