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FDA 510(k)

CG-2211 SELFCHECK ECG TRANSMITTER

K-Number: K012223 · 2001-09-10

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2001-09-10
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CG-2211 SELFCHECK ECG TRANSMITTER is the device name listed in this FDA 510(k) record. The listed applicant is Card Guard Scientific Survival , Ltd.. It received FDA 510(k) clearance on 2001-09-10 under 510(k) number K012223. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CG-2211 SELFCHECK ECG TRANSMITTER?

CG-2211 SELFCHECK ECG TRANSMITTER is a medical device that received FDA 510(k) clearance on 2001-09-10. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K012223.

When did CG-2211 SELFCHECK ECG TRANSMITTER receive FDA 510(k) clearance?

CG-2211 SELFCHECK ECG TRANSMITTER received FDA 510(k) clearance on 2001-09-10, under 510(k) number K012223.

Who is the listed applicant for CG-2211 SELFCHECK ECG TRANSMITTER?

The FDA 510(k) record lists Card Guard Scientific Survival , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CG-2211 SELFCHECK ECG TRANSMITTER?

The FDA product code for CG-2211 SELFCHECK ECG TRANSMITTER is DXH. This falls under the Hematology category.

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Other records listing Card Guard Scientific Survival , Ltd. as applicant

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Related Devices (Code: DXH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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