FDA 510(k)

TM2005 PERSONAL MEDICAL PHONE CENTER

K-Number: K024365 · 2003-01-15

ApplicantCard Guard Scientific Survival , Ltd.

Decision Date2003-01-15

Product CodeDXH

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TM2005 PERSONAL MEDICAL PHONE CENTER 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 2003-01-15 under 510(k) number K024365. 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 TM2005 PERSONAL MEDICAL PHONE CENTER?

TM2005 PERSONAL MEDICAL PHONE CENTER is a medical device that received FDA 510(k) clearance on 2003-01-15. The listed applicant is Card Guard Scientific Survival , Ltd.. The 510(k) number is K024365.

When did TM2005 PERSONAL MEDICAL PHONE CENTER receive FDA 510(k) clearance?

TM2005 PERSONAL MEDICAL PHONE CENTER received FDA 510(k) clearance on 2003-01-15, under 510(k) number K024365.

Who is the listed applicant for TM2005 PERSONAL MEDICAL PHONE CENTER?

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 TM2005 PERSONAL MEDICAL PHONE CENTER?

The FDA product code for TM2005 PERSONAL MEDICAL PHONE CENTER is DXH. This falls under the Hematology category.

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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.