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510(k) Data Aggregation
K Number
K223166Device Name
Medaica M1 Telehealth Stethoscope
Manufacturer
Date Cleared
2023-01-19
(104 days)
Regulation Number
870.1875Why did this record match?
Applicant Name (Manufacturer) :
Medaica Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Medaica M1 Telehealth Stethoscope is an electronic stethoscope that enables transmission of auscultation sound data, whereby a clinician at one location on an IP network can listen to the auscultation sounds of a patient on site or at a different location on the IP network with the signal carried on an IP connection between the two locations. The Medica M1 Telehealth Stethoscope is intended to be used by professional users in a clinical environment or by lay users in a nonclinical environment. The device is for medical diagnostics purposes only. The device is not intended for self-diagnosis.
Device Description
The Medaica M1 Telehealth Stethoscope is designed for use by professional as well as lay users in clinical or non-clinical environments. It enables three types of stethoscope exams: Heart. Lungs and Audio (Audio is for clinician only). The operation process of the Medaica M1 Telehealth Stethoscope uses four (4) primary functional elements:
- (1) The Medaica M1 Telehealth Stethoscope.
- (2) A patient's web-connected computer on which the Medaica Web Client software is running.
- (3) The Medaica Server on which the Medaica server software is running.
- (4) A clinician's web-connected computer on which the Medaica Web Client software is running.
The Medaica M1 Telehealth Stethoscope operates either in Patient Store and Forward mode or Live, online mode. Both modes are essentially similar and share the same fundamental steps: performing one or more exams using the Medaica M1 Telehealth Stethoscope, recording the data and sending to a clinician, review of the exams by the clinician, and the user receiving a summary from the clinician presenting his/her assessment and/or recommendations. While in the Patient Store and Forward mode, the Patient can send the recorded data to the clinician whenever convenient for him/her. A Live, online mode can only be executed when the clinician is available online at the same time as the patient.
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