Cleared Abbreviated

K041308 - REMOTENURSE PATIENT MONITORING SYSTEM

K041308 is an FDA 510(k) clearance for REMOTENURSE PATIENT MONITORING SYSTEM, manufactured by Webvmc, LLC. The device is a Class 2 Cardiovascular device with product code DXH cleared through the Abbreviated 510(k) pathway after a 42-day FDA review.

K041308 · Webvmc, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
42d
Days
Class 2
Risk

K041308 is an FDA 510(k) clearance for the REMOTENURSE PATIENT MONITORING SYSTEM. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Webvmc, LLC (Alpharetta, US). The FDA issued a Cleared decision on June 28, 2004 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041308

510(k) Number K041308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2004
Decision Date June 28, 2004
Days to Decision 42 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 125d · This submission: 42d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

DXH Device Classification - Class 2, Special Controls

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 284
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K041308.
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K032736 · Aerotel Medical Systems (1998) , Ltd. · Oct 2003
K041308 · REMOTENURSE PATIENT MONITORING SYSTEM
Download PDF FDA Summary Webvmc, LLC