Cleared Traditional

K133622 - MAC 2000 ECG ANALYSIS SYSTEM

K133622 is the FDA 510(k) clearance for MAC 2000 ECG ANALYSIS SYSTEM by Wipro GE Healthcare. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K133622 · Wipro GE Healthcare · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 2014
Decision
62d
Days
Class 2
Risk

K133622 is an FDA 510(k) clearance for the MAC 2000 ECG ANALYSIS SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Wipro GE Healthcare (Milwaukee, US). The FDA issued a Cleared decision on January 23, 2014 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K133622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2013
Decision Date January 23, 2014
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
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 248
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