Cleared Traditional

K080047 - CARDIOSEN'C

K080047 is an FDA 510(k) clearance for CARDIOSEN'C, manufactured by Shl Telemedicine International , Ltd.. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K080047 · Shl Telemedicine International , Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
185d
Days
Class 2
Risk

K080047 is an FDA 510(k) clearance for the CARDIOSEN'C. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Shl Telemedicine International , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on July 11, 2008 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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.

FDA 510(k) Submission Details - K080047

510(k) Number K080047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2008
Decision Date July 11, 2008
Days to Decision 185 days
Submission Type Traditional
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
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 246
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K080047.
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ECARD AND CCARD
K081471 · iRhythm Technologies, Inc. · Jun 2008
HEARTRAK AF
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HEARTEVENT, MODEL AT
K072385 · Diagnostic Devices Pty, Ltd. · Jan 2008
K080047 · CARDIOSEN'C
Download PDF FDA Summary Shl Telemedicine Inte…