Cleared Traditional

K112622 - HANDHELD ECG MONITOR

K112622 is the FDA 510(k) clearance for HANDHELD ECG MONITOR by Beijing Choice Electronic Technololgy Co., Ltd.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 315-day FDA review.

K112622 · Beijing Choice Electronic Technololgy Co., Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2012
Decision
315d
Days
Class 2
Risk

K112622 is an FDA 510(k) clearance for the HANDHELD ECG MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technololgy Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 19, 2012 after a review of 315 days - an unusually long review period, suggesting complex equivalence evaluation.

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

View all Beijing Choice Electronic Technololgy Co., Ltd. devices

Submission Details

510(k) Number K112622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2011
Decision Date July 19, 2012
Days to Decision 315 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 125d · This submission: 315d
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.

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