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510(k) Data Aggregation
K Number
K113234Device Name
MOBCARDIO SYSTEM
Manufacturer
Date Cleared
2011-11-17
(15 days)
Product Code
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MOBHEALTH INCORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MobCardio System is intended to be used by trained operators under the direct supervision of a licensed healthcare practitioner on adult populations. The device is designed to collect, transmit, and display resting 12 lead EKG data. The clinical and diagnostic evaluation of acquired EKG signals should be made by a physician, who has experience or is specialized in Cardiology. No clinical interpretation of EKG is provided.
Device Description
The MobCardio System is comprised of an EKG acquisition module (connected via a PC-USB cable), a 12-lead EKG patient cable, a medical grade laptop, and the user software. The device is used to collect, transmit, and display resting 12-lead EKG data using FDA cleared disposable EKG electrodes and manufacturer supplied 12-lead EKG patient cable. The user software is pre-installed for the user and provides necessary menus and user interfaces for displaying and printing the acquired 12-lead EKG data. The MobCardio System is compatible with any desktop or notebook computer with a suitable USB port (1.0 or above) and Windows operating system. While we offer the EKG acquisition module and the medical grade laptop as a system, the user has the option to use a personal computer that fits the requirements listed in the device user manual. Without being connected to a computer, the EKG data acquired will not be displayed and no EKG prints out can be obtained.
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