Cleared Traditional

Patient Monitor: RespArray

K220308 · Edan Instruments, Inc. · Cardiovascular
Aug 2022
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K220308 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 August 11, 2022, 190 days after receiving the submission on February 2, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K220308 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2022
Decision Date August 11, 2022
Days to Decision 190 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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