The Medaica M1 Telehealth Stethoscope is an FDA-cleared Class II medical device under 510(k) number K223166.
The FDA-cleared system includes the Medaica M1 Telehealth Stethoscope together with the Medaica system software, designed for use by professional and lay users in clinical and non-clinical environments. It supports heart, lung, and audio exams, with audio available for clinician review.
The Medaica M1 Telehealth Stethoscope is not intended to replace emergency care or a physician evaluation. If you are experiencing chest pain, shortness of breath, fainting, stroke-like symptoms, or another medical emergency, call 911 or seek immediate medical attention.
For additional information, please see the FDA 510(k) information below or contact info@medaica.com.
https://www.accessdata.fda.
