Cleared Special

K052556 - CG-7000DX-BT ECG RECORDER/TRANSMITTER

K052556 is an FDA 510(k) clearance for CG-7000DX-BT ECG RECORDER/TRANSMITTER, manufactured by Card Guard Scientific Survival , Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Special 510(k) pathway after a 115-day FDA review.

K052556 · Card Guard Scientific Survival , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2006
Decision
115d
Days
Class 2
Risk

K052556 is an FDA 510(k) clearance for the CG-7000DX-BT ECG RECORDER/TRANSMITTER. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on January 9, 2006 after a review of 115 days - within the typical 510(k) review window.

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. 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.

View all Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K052556

510(k) Number K052556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date January 09, 2006
Days to Decision 115 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
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

DXH Device Classification - Class 2, Special Controls

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 115
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