Cleared Traditional

K972603 - ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B

K972603 is an FDA 510(k) clearance for ELECTROCARDIOGRAPHS MODELS 110B, manufactured by Dr. Lee Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 243-day FDA review.

K972603 · Dr. Lee Co., Ltd. · Cardiovascular device
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Mar 1998
Decision
243d
Days
Class 2
Risk

K972603 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPHS MODELS 110B, 120B AND 310B. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Dr. Lee Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 243 days - an extended review cycle.

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.

View all Dr. Lee Co., Ltd. devices

FDA 510(k) Submission Details - K972603

510(k) Number K972603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date March 11, 1998
Days to Decision 243 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 125d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 333
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K972603.
EASY ECG PC BASED ELECTROCARDIOGRAPH
K972996 · Ates Medical S.R.L. · Apr 1998
BIOLOG 3000 ELECTROCARDIOGRAPH
K974351 · Micromedical, Inc. · Apr 1998
M1765A ECG MANAGER
K974746 · Hewlett-Packard Co. · Mar 1998
FORMULA FOR ARCHIMED
K974079 · Biosound Esaote, Inc. · Jan 1998
HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
K973437 · Hewlett-Packard GmbH · Dec 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER LP6/100
K972746 · Alexander Mfg. Co. · Oct 1997