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FDA 510(k)

PMP4 SELFCHECK ECG

K-Number: K042254 · 2005-01-13

ApplicantCard Guard Scientific Survival , Ltd.
Decision Date2005-01-13
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PMP4 SELFCHECK ECG 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 2005-01-13 under 510(k) number K042254. 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 PMP4 SELFCHECK ECG?

PMP4 SELFCHECK ECG is a medical device that received FDA 510(k) clearance on 2005-01-13. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K042254.

When did PMP4 SELFCHECK ECG receive FDA 510(k) clearance?

PMP4 SELFCHECK ECG received FDA 510(k) clearance on 2005-01-13, under 510(k) number K042254.

Who is the listed applicant for PMP4 SELFCHECK ECG?

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 PMP4 SELFCHECK ECG?

The FDA product code for PMP4 SELFCHECK ECG is DXH. This falls under the Hematology category.

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

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.

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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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