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510(k) Data Aggregation
K Number
K121144Device Name
ELECTRONIC STETHOSCOPE
Manufacturer
Date Cleared
2012-09-26
(163 days)
Product Code
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
SHARP CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BM-520 Electronic Stethoscope is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from heart, lungs, blood vessels, and other internal organs. It can be used on any person undergoing a physical assessment.
Device Description
The Sharp Electronic Stethoscope Model BM-520 is an electronic stethoscope to auscultate sounds from heart, lung, blood vessels, and other internal organs. It can be used on adults undergoing a physical assessment. The sounds can also be transmitted to an appropriately configured receiving device via Bluetooth® wireless communication.
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K Number
K113865Device Name
PULTOL
Manufacturer
Date Cleared
2012-03-21
(82 days)
Product Code
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
SHARP CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sharp Pulse Oximeter Model BM-500 and BM-510 is a non-invasive pulse oximeter indicated for use in the spot-check measurement and display of arterial blood oxygen saturation (SpO2) and pulse rate in hospitals or primary care settings.
Device Description
The Sharp Pulse Oximeter is a multi-parameter module comprising of a main unit (BM-500) and the SpO2 Sensor (BM-510) connected via the sensor cord. The device operates continuously to provide spot-check measurements of oxygen saturation and pulse when a patient's finger is inserted into the sensor and the ON button is depressed.
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