Search Results
Found 1 results
510(k) Data Aggregation
K Number
K230613Device Name
SKEEPER
Manufacturer
Smartsound Corporation
Date Cleared
2023-08-02
(149 days)
Product Code
DQD, DOD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
Smartsound Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SKEEPER is an electronic stethoscope that collects, fitters, and amplifies the sound of a person's heart, lungs, and abdomen. It is intended for use by professional users in clinical environments or by lay users in non-clinical environments. It is not intended for self-diagnosis.
Device Description
SKEEPER is an electronic stethoscope used to collect and measure the sounds inside the body, and it consists of an electronic stethoscope (SM-300) and a mobile application (SKEEPER PRO APP).
When the diaphragm at the bottom of the SM-300 is lightly attached to the body part to be measured, such as the heart, lungs, or abdomen, the diaphragm vibrates due to the sound inside the human body and generates a sound. This sound is collected using a microphone and converted into an electrical signal. After that, the electrical signal is filtered and amplified for each frequency band set according to the measurement site, amplified, and output to earphones or transmitted to the SKEEPER APP installed on the mobile platform, and then the sound is output the earphone or speaker of the corresponding platform.
The SKEEPER PRO APP graphs the waveform of the sound received by the SM-300. It also stores and plays back sound data and analyzes heart rate.
Ask a Question
Page 1 of 1