Cleared Traditional

K033488 - CMI MAGNETOCARDIOGRAPH

K033488 is an FDA 510(k) clearance for CMI MAGNETOCARDIOGRAPH, manufactured by Cmi Cardiomag Imaging, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K033488 · Cmi Cardiomag Imaging, Inc. · Cardiovascular device
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Jul 2004
Decision
246d
Days
Class 2
Risk

K033488 is an FDA 510(k) clearance for the CMI MAGNETOCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Cmi Cardiomag Imaging, Inc. (Schenectady, US). The FDA issued a Cleared decision on July 7, 2004 after a review of 246 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 Cmi Cardiomag Imaging, Inc. devices

FDA 510(k) Submission Details - K033488

510(k) Number K033488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2003
Decision Date July 07, 2004
Days to Decision 246 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
121d slower than avg
Panel avg: 125d · This submission: 246d
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 369
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K033488.
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
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MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K042177 · Ge Medical Systems Information Technologies · Aug 2004
CARDIOVIT AT-102
K031557 · Schiller AG · Apr 2004
ELI 200+ AUDICOR
K031182 · Mortara Instrument, Inc. · Jul 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
K031422 · Philips Medical Systems · Jul 2003