Cleared Special

K032736 - HEART 2006

K032736 is the FDA 510(k) clearance for HEART 2006 by Aerotel Medical Systems (1998) , Ltd.. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Special 510(k) pathway after a 29-day FDA review.

K032736 · Aerotel Medical Systems (1998) , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
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Oct 2003
Decision
29d
Days
Class 2
Risk

K032736 is an FDA 510(k) clearance for the HEART 2006. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Aerotel Medical Systems (1998) , Ltd. (Hasbrouck Heights, US). The FDA issued a Cleared decision on October 3, 2003 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aerotel Medical Systems (1998) , Ltd. devices

Submission Details

510(k) Number K032736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2003
Decision Date October 03, 2003
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 93
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