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)
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.

View all Webvmc, LLC devices

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
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 Peers - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 161
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K041308.
CG-7000DX-BT ECG RECORDER/TRANSMITTER
K052556 · Card Guard Scientific Survival , Ltd. · Jan 2006
PMP4 MEDICAL WEB CENTER
K050940 · Card Guard Scientific Survival , Ltd. · Jul 2005
PMP4 SELFCHECK ECG
K042254 · Card Guard Scientific Survival , Ltd. · Jan 2005
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
K023689 · Card Guard Scientific Survival , Ltd. · Jan 2003
TM2005 PERSONAL MEDICAL PHONE CENTER
K024365 · Card Guard Scientific Survival , Ltd. · Jan 2003
TM2000, MODEL 1
K013879 · Card Guard Scientific Survival , Ltd. · Feb 2002