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510(k) Data Aggregation
K Number
K191667Device Name
Electronic Stethoscope
Manufacturer
Date Cleared
2019-12-18
(180 days)
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
Hefei Mintti Medical Technology Co., Ltd. China
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Electronic Stethoscope is intended for the detection and amplification of sounds from the heart, lungs and other internal organs with the use of a selective frequency. It can be used on any person undergoing a physical assessment for medical diagnostic purposes only.
Device Description
The Mintti Electronic Stethoscope, model smartho-D2 is a healthcare device that picks up sounds of the heart, lungs and other internal organs with the use of selective frequency ranges from 10-2000Hz. After amplification and filtering, the sounds are transferred to the user's ears via an wired-connected headset.
The user interface includes a 5-button keypad and an 1.3' OLED display with a blue back-light. Sound processing is carried out with the aid of a digital signal processor.
The smartho-D2 does not incorporate any off-the-shelf (OTS) software, and it incorporates embedded software which controls all the features of the product, including sound capture, digital signal processing, volume control, OLED display and Bluetooth function.
The smartho-D2 operates on a certificated rechargeable 3.7V/2000mAh lithium ion battery.
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