Cleared Special

K063042 - CARDIOMEM CM 3000-12BT

K063042 is an FDA 510(k) clearance for CARDIOMEM CM 3000-12BT, manufactured by Getemed Medizin- Und Informationstechnik AG. The device is a Class 2 Cardiovascular device with product code MWJ cleared through the Special 510(k) pathway after a 239-day FDA review.

K063042 · Getemed Medizin- Und Informationstechnik AG · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
239d
Days
Class 2
Risk

K063042 is an FDA 510(k) clearance for the CARDIOMEM CM 3000-12BT. Classified as Electrocardiograph, Ambulatory (without Analysis) (product code MWJ), Class II - Special Controls.

Submitted by Getemed Medizin- Und Informationstechnik AG (Great Neck, US). The FDA issued a Cleared decision on May 30, 2007 after a review of 239 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063042

510(k) Number K063042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2006
Decision Date May 30, 2007
Days to Decision 239 days
Submission Type Special
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
114d slower than avg
Panel avg: 125d · This submission: 239d
Pathway characteristics
Modification to existing cleared device.

MWJ Device Classification - Class 2, Special Controls

Product Code MWJ Electrocardiograph, Ambulatory (without Analysis)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - MWJ Electrocardiograph, Ambulatory (without Analysis)

All 63
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