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FDA 510(k)

VITALCAREGIVING SYSTEM

K-Number: K051544 · 2005-10-07

ApplicantAdvanced Monitoring Caregiving, Inc.
Decision Date2005-10-07
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VITALCAREGIVING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Monitoring Caregiving, Inc.. It received FDA 510(k) clearance on 2005-10-07 under 510(k) number K051544. 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 VITALCAREGIVING SYSTEM?

VITALCAREGIVING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-10-07. The listed applicant is Advanced Monitoring Caregiving, Inc.. The 510(k) number is K051544.

When did VITALCAREGIVING SYSTEM receive FDA 510(k) clearance?

VITALCAREGIVING SYSTEM received FDA 510(k) clearance on 2005-10-07, under 510(k) number K051544.

Who is the listed applicant for VITALCAREGIVING SYSTEM?

The FDA 510(k) record lists Advanced Monitoring Caregiving, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITALCAREGIVING SYSTEM?

The FDA product code for VITALCAREGIVING SYSTEM is DXH. This falls under the Hematology category.

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Official Source

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

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