Cleared Traditional

Electrocardiograph

K212278 · Edan Instruments, Inc. · Cardiovascular
Apr 2022
Decision
261d
Days
Class 2
Risk

About This 510(k) Submission

K212278 is an FDA 510(k) clearance for the Electrocardiograph, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on April 7, 2022, 261 days after receiving the submission on July 20, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K212278 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 2021
Decision Date April 07, 2022
Days to Decision 261 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DPS — Electrocardiograph
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2340

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