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FDA 510(k)

REMOTENURSE PATIENT MONITORING SYSTEM

K-Number: K041308 · 2004-06-28

ApplicantWebvmc, LLC
Decision Date2004-06-28
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REMOTENURSE PATIENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Webvmc, LLC. It received FDA 510(k) clearance on 2004-06-28 under 510(k) number K041308. 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 REMOTENURSE PATIENT MONITORING SYSTEM?

REMOTENURSE PATIENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2004-06-28. The listed applicant is Webvmc, LLC. The 510(k) number is K041308.

When did REMOTENURSE PATIENT MONITORING SYSTEM receive FDA 510(k) clearance?

REMOTENURSE PATIENT MONITORING SYSTEM received FDA 510(k) clearance on 2004-06-28, under 510(k) number K041308.

Who is the listed applicant for REMOTENURSE PATIENT MONITORING SYSTEM?

The FDA 510(k) record lists Webvmc, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMOTENURSE PATIENT MONITORING SYSTEM?

The FDA product code for REMOTENURSE PATIENT MONITORING 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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