Cleared Traditional

electrocardiograph: SE-1202

K210140 · Edan Instruments, Inc. · Cardiovascular
Oct 2021
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K210140 is an FDA 510(k) clearance for the electrocardiograph: SE-1202, a Electrocardiograph (Class II — Special Controls, product code DPS), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on October 1, 2021, 255 days after receiving the submission on January 19, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2340.

Submission Details

510(k) Number K210140 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2021
Decision Date October 01, 2021
Days to Decision 255 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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