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510(k) Data Aggregation
K Number
K013725Device Name
MEDITRON II THESTERTHOSCOPE SYSTEM
Manufacturer
MEDITRON AS
Date Cleared
2002-01-30
(82 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
MEDITRON AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use as a diagnostic aid in patient diagnosis, treatment, and monitoring. It amplifies sounds from the body's internal organs, mainly the heart and lungs. Included with the system is a manual 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 system also includes computer-aided recordings and storage of these sounds along with other patient information.
Device Description
The Meditron electronic stethoscope system is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies, records, plays back, and transmits sounds associated with the heart, arteries, and veins and other internal organs. The modification involves the addition of a 5-lead electrocardiograph to produce an ECG on the PC monitor to enable the healthcare practitioner to synchronize the phonocardiogram with the beginning of the heart cycle.
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K Number
K991367Device Name
MEDITRON STETHOSCOPE SYSTEM
Manufacturer
MEDITRON AS
Date Cleared
1999-07-19
(90 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
MEDITRON AS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Meditron Stethoscope System is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It amplifies sounds from the bodys internal organs, mainly the heart and respitatory and circulatory organs. It provides computer-aided recordings of these sounds and stores these recordings along with other appropriate patient information.
Device Description
The Meditron stethoscope system is intended for use as a diagnostic aid in patient diagnosis, treatment and monitoring. It consists of four major components: electronic stethoscope (thestethoscope), distributor (thedistributor), connector (thecomnector), and CD software (theanalyzer). Thestethoscope amplifies sounds from the body's internal organs, mainly the heart and respiratory and circulatory organs, without introducing signals or energy into the body. Thedistributor is a co-listening device that has been specially developed for teaching purposes as it permits up to six persons to listen to the patient at the same time. Thedistributor can also be used during maternity check-ups to permit the physician and expectant mother to simultaneously listen to the sounds. Theconnector (connection box and cables) links thedistributor to the sound card of a personal computer (PC). Theanalyzer is a Microsoft Windows-based CD software application supplied with theconnector and is designed to provide computeraided recordings with the electronic stethoscope and to store these recordings along with other appropriate patient information.
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