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Card Guard, Model CG-9000

by Card Guard Scientific Survival, Ltd.

510(k) K924486

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 · Traditional NumberK924486 Date31 Oct 1994ClearedStatusActive

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  • Withdrawn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, 23 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 Card Guard, Model CG-9000 is a transmitter and receiver electrocardiograph device that operates via telephone. It is classified as a Class II medical device in the cardiovascular specialty category.

This device is manufactured by Card Guard Scientific Survival, Ltd. and received FDA 510(k) clearance with K number K924486 on October 31, 1994. It is regulated under product code DXH and falls under regulation number 870.2920.

Other devices from Card Guard Scientific Survival, Ltd.

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Questions

AI-generated answers, 23 Sep 2026

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

  • What is the Card Guard CG-9000 device used for?

    The Card Guard CG-9000 is a transmitter and receiver electrocardiograph device that operates via telephone, designed for cardiovascular monitoring and diagnostic purposes.

  • What is the regulatory status of the Card Guard CG-9000?

    The Card Guard CG-9000 received FDA 510(k) clearance with K number K924486 on October 31, 1994, and is classified as a Class II medical device in the cardiovascular specialty category under product code DXH.

  • How is the Card Guard CG-9000 supplied and what are its storage requirements?

    The device is supplied by Card Guard Scientific Survival, Ltd. with specific storage requirements not detailed in the provided information. Users should consult the manufacturer's instructions for proper storage conditions.

  • Is the Card Guard CG-9000 a single-use or reusable device?

    The provided information does not specify whether the Card Guard CG-9000 is designed for single-use or multiple uses. Users should refer to the manufacturer's instructions for proper usage and disposal guidelines.