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510(k) Data Aggregation
K Number
K061780Device Name
TELEPHONE ELECTROCARDIOGRAPH TRANSMITTER AND RECEIVER, TTM FOR WINDOWS +
Manufacturer
ROZINN ELECTRONICS, INC.
Date Cleared
2006-09-15
(81 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
ROZINN ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TTM For Windows + is used for Transtelephonic Cardiac Monitoring. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. It only presents the data such as one, two or twelve lead ECG and pacer spikes. There is no age or other physiological limitations using this device TTM For Windows +. It is intended that TTM For Windows + will be used only by a physician and trained technicians. It also acts as a database for patients with or without pacemakers or implantable cardioverter defibrillators.
Device Description
The TTM For Windows + system is designed and manufactured by Rozinn Electronics Inc. It is a PC based computer that is used for Transtelephonic cardiac monitoring. It consists of a standard PC computer, monitor, printer and proprietary download module. It provides the ability to download, present and store the ECG signal via a phone using commercially available transtelephonic cardiac monitoring devices. TTM For Windows + does not come in contact with the patient. TTM For Windows + does not perform any diagnostic functions. It only presents the data. There is no age or other physiological limitations using this device TTM For Windows +.
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K Number
K042463Device Name
HOLTER PLUS
Manufacturer
ROZINN ELECTRONICS, INC.
Date Cleared
2004-09-22
(9 days)
Product Code
DQK
Regulation Number
870.1425Why did this record match?
Applicant Name (Manufacturer) :
ROZINN ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Holter Plus ™ Ambulatory ECG Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient's ambulatory ECG data. This product allows a trained physician or health care professional, after having performed a long-term continuous electrocardiograph (ECG) recording on a digital flash memory Holter recorder, to download and analyze the data from the recorder, review it and produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patients response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery, and/or evaluation of patients with pacemakers.
The need to record, review, edit and archive these ambulatory ECG data is most commonly encountered in the Cardiology areas of the hospital during cardiac patient assessment. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.
Device Description
The Holter Plus™ Ambulatory ECG Analysis System is an ambulatory ECG analysis system comprised of a standard computer display, a standard Personal Computer (PC) based system, and hardware used to acquire the ambulatory ECG data (specifically the Braemar RZ153+ data recorder - 510(k) K993618). The Holter Plus™ Ambulatory ECG Analysis System System can provide the retrospective display, storage and recording (or printing) of ambulatory ECG waveform and annotated data that is provided by the Braemar RZ153+ recorder.
The Holter Plus™ Ambulatory ECG Analysis System allows the assessment and review of a patient's recorded ambulatory ECG records, and presents an analysis for the clinician's review and editing. This product performs a high-speed analysis of the data, classify the data into appropriate ECG morphologies, and allow the results to be printed if desired. The Holter Plus TM does not perform any diagnosis of data, but only displays the ECG morphologies, and associated curves calculated form the data such as heart rate trends and RR variability in graphical form. The physician will be able to review, edit, and print the data collected. The Holter Plus™ will provide information such as when patient-activated events occurred.
The Holter Plus™ Ambulatory ECG Analysis System provides storage of patient data for archiving and printing various reports. This includes waveform and patient parameter data for the ambulatory ECG data and assessment. The waveform and parameter data that has been stored in a patient file can be retrieved and reviewed on the display or printed out on a laser printer.
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K Number
K022540Device Name
CARDIO ID+(RZ153+)
Manufacturer
ROZINN ELECTRONICS, INC.
Date Cleared
2002-10-24
(84 days)
Product Code
DSH
Regulation Number
870.2800Why did this record match?
Applicant Name (Manufacturer) :
ROZINN ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Holter Recorder Rz153+/ Cardio ID+ is to perform ambulatory ECG and impedance recording, on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording. The data is intended to be downloaded to an analysis software package after the recording is completed.
Detection of Arrhythmia. The Rozinn 153+ is indicated for use in continuous monitoring of Cardiac rhythm when intermittent arrhythmia are suspected due to patient symptoms such as palpitations, transient ischemic attacks, syncope, and the symptoms as determined by the physician. Efficacy of treatment using the 153+ is indicated for use to determine whether current pharmacological treatment (s) of known arrhythmia is effective by measuring the frequency and duration of the arrhythmia compared to the frequency and duration prior to treatment. Pacemaker evaluation is also indicated for use to evaluate the function of implanted pacemakers to insure that the pacemaker is functioning within prescribed limits. This device is to be used only by the order of a physician
Device Description
The basic operation of the Holter Recorder RZ153+ is to collect and store multiple channels of ECG data along with impedance measurements. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.
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K Number
K021517Device Name
ABP FOR WINDOWS
Manufacturer
ROZINN ELECTRONICS, INC.
Date Cleared
2002-07-24
(75 days)
Product Code
DSK
Regulation Number
870.1110Why did this record match?
Applicant Name (Manufacturer) :
ROZINN ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The APB for Windows is a software package to be used by a trained physician or health care provider to load, download, review and print data from the Mobile-O-Graph blood pressure monitor. The software will store and playback systolic, diastolic pressures as well as patients heart rates to be reviewed by a trained physician.
Device Description
The ABP for Windows Software is a software designed to be used in conjunction with I.E.M's Mobile-O-Graph Blood Pressure Monitor, Model ABP Control (K964235). The software will allow the user to program the Mobile-O-Graph using the software by inputting patient identification, protocols and setting recorder clock. The software will have the ability to download the data recorded from the Mobile-O-Graph to the computer to be reviewed by a trained professional. The software will allow the data to be printed and e-mailed in PDF or HTML format if desired. The ABP for Windows does not perform any diagnosis or provide any interpretation of data, it can only display and print the downloaded data such as systolic, diastolic, heart rates and mean arterial blood pressure in tabular or graphical form which was recorded by the Mobile-O-Graph. The physician will be able to review, edit and print the data collected. The ABP for Windows will provide information such as when patient events occurred , errors during recording and when day and night were marked on the Mobile-O-Graph. The software ABP for windows will be shown to be substantially equivalent to the software which is provided by I.E.M.'s Mobile-O-Graph Blood Pressure Monitor, Model ABP Control.
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K Number
K020213Device Name
NETLINK/NETSCAN
Manufacturer
ROZINN ELECTRONICS, INC.
Date Cleared
2002-04-05
(73 days)
Product Code
DXH
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
ROZINN ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Netlink/Netscan is a transmission software which will transmit ECG, ambulatory blood pressure, EKG, spirometry, and any other data files from a remote site to a central station for analysis using a modem, cable modem, ISDN line, T1 lines, DSL, Internet or Intranet and send the analyzed data back to the remote site from the central site using the same transmission media.
Device Description
Netlink/Netscan is an accessory to Northeast Monitoring's Holter for Windows Holter Scanner (K930564) that sends recorded cardiac ECG data from remote sites to a central site using standard TCP/IP transfer protocols and where the central site is equipped with Northeast Monitoring's Holter for Windows Holter Scanner for analysis. equipped Monitoring's Holter for Windows Holter Scanner software analyzes the ECG and provides reports on a variety of cardiac data. The cardiac data which is analyzed and provides reports on eforms and patterns of consecutive waveforms. The analysis is then returned to the remote site and interpreted by trained medical personnel to diagnose patients with cardiac rhythm patterns.
Netlink/Netscan is an accessory that provides a means to transmit data to and from Northeast Monitoring's Holter for Windows Holter Scanning System . Data can be transferred via modem, cable modems, ISDN lines, T1 lines, DSL, Internet or Intranet. All transferred data is encrypted and is only accessed through a password controlled by the remote and central sites. Netlink/Netscan software contains data checks to prevent the loss or corruption of data during transmission. Nelink/Netscan will resend data if transmission is interrupted.
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