Cleared Traditional

K090936 - SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090936 · Contec Medical System Co., Ltd. · Cardiovascular device
Aug 2009
Decision
145d
Days
Class 2
Risk

K090936 is an FDA 510(k) clearance for the SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Contec Medical System Co., Ltd. (Zhong Shan, Shanghai, CN). The FDA issued a Cleared decision on August 25, 2009 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K090936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2009
Decision Date August 25, 2009
Days to Decision 145 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 140d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 14
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