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510(k) Data Aggregation
K Number
K103427Device Name
MOBILEECG SYSTEM
Manufacturer
MEMTEC CORP.
Date Cleared
2011-03-24
(122 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MEMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MobileECG System is intended to provide an interpretation of the resting 12 lead ECG in all situations, whether in a hospital or primary care setting. It is capable of diagnosing all commonly recognized ECG abnormalities such as myocardial infarction (MI), including acute MI, ventricular hypertrophy, abnormal ST-T changes and common abnormalities of rhythm.
The MobileECG System is intended for use in adults and children of any age from birth upwards.
The MobileECG System's interpretation software is not intended as sole means of diagnosis and is offered to physicians and clinicians on an advisory basis only in conjunction with the physician's knowledge of ECG.
Device Description
The MobileECG System is an electrocardiograph consisting of Model 950-12LR HHC module and CardioVu interpretation software.
The Model 950-12LR HHC module is a small, light weight, single battery, wireless module designed to transmit 12Lead electrical heart activity of a patient to a computer. This module will transmit a patient's ECG wirelessly to a laptop, netbook, tablet, or desktop computer containing the CardioVu interpretation software from up to 100 feet away.
Elimination of the cable reduces a source of artifact resulting in high-quality ECG tracings. Wireless dedicated and secure communication links the Model 950-12LR HHC module to CardioVu interpretation software.
The CardioVu software receives, displays, and stores the patients ECG data wirelessly on a laptop, netbook, tablet, or desktop computer in "real time". The software also has the data using ECG algorithms for review by a physician or other qualified medical professional as an advisory basis only in conjunction with the physician's knowledge of ECG. The wireless feature allows the patient not to be tethered to the computer or a bulky box thus reducing motion artifacts caused by movement of the connecting cables and providing comfort to the patient.
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K Number
K102723Device Name
MODEL 950-12L HOLTER RECORDER WITHOUT ANALYSIS
Manufacturer
MEMTEC CORP.
Date Cleared
2010-12-09
(79 days)
Product Code
MWJ
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
MEMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Model 950-12L Holter recorder is intended to record continuous data for up to 120 hours for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as:
- Palpitations, shortness of breath, chest pain, syncope
- Evaluating pacemakers
- Heart rate variability's
- Evaluating medications
- Clinical studies
This is a prescriptive device and is to be used by trained physicians and other licensed medical professionals only.
The Memtec Model 950-12L recorder does not perform diagnostics. The data provided shall be used by physicians for diagnostic evaluations.
The Memtec Model 950-12L recorder is not intended for infants weighing less than 22 Lbs. (10 Kg).
Device Description
The Model 950-12L is a small, light weight, single battery device designed for the recording of ECG data collected from ambulatory patients. The device can record and store multiple of channels of data for up to 120 hours on a SD Card. The device has a resolution of 12-bits with a fundamental sampling frequency of 6K (SPS) per channel with selectable storage rates of 128, 256, 512, or 1024 SPS and is stored un-compressed on a removable SD or SDHC Storage Card. The data can be downloaded via USB 2.0 or removable of SD Card. Data integrity is provided by including Patient ID/Date/Time Stamps and a CRC-16 check on the recording every 2 minutes. The large LCD provides real time patient ECG signals enabling lead placement confirmation during patient hook-up. The Model 950-12L provides up to 48 hours of continuous operation using one AA alkaline or 120 hours using a Lithium "AA" battery.
The recorder is not capable of any diagnosis, nor can it provide any interpretation of the data. The device accommodates compatibility with various OEM Holter playback systems.
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K Number
K944180Device Name
MODEL 700
Manufacturer
MEMTEC CORP.
Date Cleared
1997-03-07
(924 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
MEMTEC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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