Search Results
Found 1 results
510(k) Data Aggregation
K Number
K160016Device Name
Steth IO
Manufacturer
STRATOSCIENTIFIC, INC.
Date Cleared
2016-07-15
(192 days)
Product Code
DQD
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
STRATOSCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The StratoScientific Steth IO Stethoscope and Phonocardiogram Model 1.0 is intended for medical diagnostic purposes only. It may be used for the detection of sounds from the heart, and lungs with the use of selective frequency ranges. It has been tested for use on adults undergoing a physical assessment.
Device Description
Steth IO is an acoustic device that is used in conjunction with a smartphone to collect heart and lung sounds. Steth IO attaches to the back of the smartphone and contains an acoustic wave guide that channels sound from the Steth IO chest piece to the smartphone's microphone, while also acting as a protective covering for the phone. The Steth IO smartphone application software performs real-time analysis so the user can hear the sounds using headphones, and visualize the sound using the on-screen phonocardiogram. The device is capable of recording sound and phonocardiogram data, allowing healthcare providers to capture biological sounds and send the data to other healthcare providers or for review at a later time. Steth IO is intended for use as a diagnostic aid, enabling the healthcare provider to identify sounds and any abnormalities that may be present.
Ask a Question
Page 1 of 1