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510(k) Data Aggregation
K Number
K220470Device Name
Smart Wireless Stethoscope
Manufacturer
Date Cleared
2022-05-23
(94 days)
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Hulu Devices Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Smart Wireless Stethoscope enables amplification, filtering, and transmission of auscultation sounds from the heart, lungs, bowel, arteries, and veins. A medical professional at one location on network can listen to the auscultation sounds of a patient on site or at a different location on the network. The device is intended for use on pediatric and adult patients. The device is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is not intended for self-diagnosis.
Device Description
The proposed smart wireless stethoscope is made of a Bluetooth® stethoscope and a companion medical mobile application that runs on a smartphone or a tablet. The stethoscope picks human body sounds with an acoustic structure that is similar to the chest piece of a traditional stethoscope. Then the sounds are converted to electrical audio signals by a microphone in the device. The electrical audio signals are further processed and transmitted through Bluetooth® protocol. The device has three models STEMO300, STEMO500 and STEMO700. All the three models can work with the companion app running on a smartphone or tablet. When they work this way, the stethoscope transmits audio to the app and the sounds can be further processed in the app. The app provides functions such as amplification, filtering, recording, sharing, etc. STEMO500 and STEMO700 have an ambient noise cancelling option while STEMO300 not. Unlike STEMO300 or STEMO500, STEMO700 has an option to directly transmit audio to paired Bluetooth earphones.
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K Number
K180335Device Name
Accutension Smartphone Auscultatory Blood
Manufacturer
Date Cleared
2018-03-08
(30 days)
Regulation Number
870.1120Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Hulu Devices Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Accutension Smartphone Auscultatory Blood Pressure Kit is intended for professionals or home users to nonautomatically measure systolic and diastolic blood pressure on adults by detecting Korotkoff sounds and measure pulse rate on adults by detecting oscillometry. This device is not indicated for children, heart failure patients and critical patients.
Device Description
The Accutension Smartphone Auscultatory Blood Pressure Kit (Model XYZ-110) is a non-invasive blood pressure measurement system for professionals and home users to nonautomatically measure systolic and diastolic blood pressure and pulse rate. It utilizes advanced pressure sensing module to transfer cuff pressure value to an iOS App via established Bluetooth connection between the module and the iOS device during measurement, meanwhile a stethoscope detects Korotkoff sounds and transfers the sound signal to the smartphone via its earphone jack. Both the cuff pressure and auscultatory sounds are visualized in the app and a user can determine the systolic and diastolic blood pressure by finding the cuff pressures on the first and last Korotkoff sounds. It automatically calculates the pulse rate based on cuff pressure oscillometry. This device consists of 5 parts, arm cuff, pressure sensing module, hand pump (bulb) with airflow valve, stethoscope with earphone plug and charging cable.
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