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Personal ECG Transmitter, Model CG-6550

by Card Guard Scientific Survival, Ltd.

510(k) K003220

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK003220 Date8 Nov 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXH
FDA applicant
Card Guard Scientific Survival , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.2920
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Personal ECG Transmitter, Model CG-6550, is a personal 3-lead electrocardiograph transmitter. It is designed to capture ECG signals from a patient and transmit them for remote analysis to assist in the detection of rhythm disorders and ST-segment changes.

This device is classified as a Class II transmitter and receiver for telephone electrocardiographs. It has received FDA 510(k) clearance under the product code DXH.

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