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Found 5 results
510(k) Data Aggregation
K Number
K090493Device Name
SIGNAL
Manufacturer
ZARGIS MEDICAL CORP.
Date Cleared
2009-08-07
(163 days)
Product Code
DQD, DOD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ZARGIS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Signal is an electronic device intended to support the physician in the evaluation of heart sounds, lung sounds, bowel sounds and other acoustic signals in patients. The device allows for the recording of multiple, simultaneous acoustic signals and includes a single-lead electrocardiograph that produces a visual display of the electrocardiogram (ECG) on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle. The ECG is not intended for diagnostic use. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files. Signal is intended for use by healthcare professionals only.
Device Description
Signal™ is an electronic auscultation device intended to acquire, record, and display heart sounds and other body sounds. Signal includes a single-lead electrocardiograph to produce an ECG on the laptop monitor to enable the health care professional to synchronize the phonocardiogram with the beginning of the heart cycle. The device also allows the sharing of data through the Internet and provides a means to attach patient information to the stored sound files.
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K Number
K083309Device Name
ZARGIS ACOUSTIC CARDIOSCAN, VERSION 9.33
Manufacturer
ZARGIS MEDICAL CORP.
Date Cleared
2009-02-13
(95 days)
Product Code
DQD, DQC
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ZARGIS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zargis Acoustic Cardioscan, (ZAC) is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds. that may be present. Identified sounds include S1, S2, and suspected murmurs.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
Device Description
The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.
The complete system is a CD comprising software and instructions for use with an included USB transceiver for connection with a PC and capable of wireless communication with a Bluetooth-enabled electronic stethoscope.
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K Number
K060197Device Name
ZARGIS ACOUSTIC CARDIOSCAN (ZAC), MODEL ZAC 6.28
Manufacturer
ZARGIS MEDICAL CORP.
Date Cleared
2006-03-29
(62 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ZARGIS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zargis Acoustic Cardioscan, (ZAC), is an electronic auscultatory device, intended to provide support to the physician in the evaluation of patients' heart sounds.
The product acquires and records the acoustic signals of the heart and analyzes these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs. The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
Device Description
The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds.
The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.
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K Number
K042128Device Name
MODIFICATION TO ZARGIS ACOUSTIC CARDIOSCAN (ZAC)
Manufacturer
ZARGIS MEDICAL CORP.
Date Cleared
2004-09-08
(33 days)
Product Code
DQD, DQC
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ZARGIS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zargis Acoustic Cardioscan, (ZAC), is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
Device Description
The ZAC is a computer-assisted auscultatory device, intended to provide support to the target users in the evaluation of heart sounds and murmurs. The product will acquire and record the acoustic signal of the heart, over appropriate regions of the chest, and then analyze these signals. The analysis procedure will evaluate sounds of the heart and aid healthcare providers in identifying murmurs. Results are presented to the user in near real-time.
As a complete system, the ZAC consists of an electronic stethoscope, a laptop computer. software, and a printer.
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K Number
K031517Device Name
ZARGIS ACOUSTIC CARDIOSCAN
Manufacturer
ZARGIS MEDICAL CORP.
Date Cleared
2004-05-26
(377 days)
Product Code
DQD, DQC
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
ZARGIS MEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zargis Acoustic Cardioscan, (ZAC), is an electronic auscultatory device, intended to provide support to the physician in the evaluation of heart sounds in patients.
The product will acquire and record the acoustic signals of the heart and analyze these signals. The analysis procedure will identify specific heart sounds that may be present. Identified sounds include S1, S2, and suspected murmurs.
The device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis.
The interpretations of heart sounds offered by the Zargis Acoustic Cardioscan are only significant when used in conjunction with physician over-read as well as consideration of all other relevant patient data.
Device Description
The ZAC is an electronic auscultatory device intended to acquire, record, and analyze heart sounds. Heart sounds identified are S1, S2 and suspected murmurs.
The complete system is comprised of an electronic stethoscope, a notebook computer, software, a printer and an isolation transformer.
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