Is Stethophone a medical device?

Stethophone is a Class II medical device that has been reviewed and evaluated by the U.S. Food and Drug Administration (FDA) and has been found to be in compliance with the regulatory requirements for safety and effectiveness. After regulatory clearance, we continue to adhere to post-market surveillance requirements. See information about Stethophone’s unique device identification:  

https://accessgudid.nlm.nih.gov/devices/00860011561705 

Sparrow’s approach is based on providing the highest quality of our medical devices. Stethophone is developed and maintained with conformity to many international and national standards, guidances and requirements to deliver the best experience with our medical devices. 

Additionally, Sparrow BioAcoustics, the manufacturer of the Stethophone application, has implemented its Health Insurance Portability and Accountability Act (HIPAA) compliance program and has received the HIPAA Seal of Compliance as means of verification.  

Sparrow BioAcoustics maintains an ISO 13485 certified Quality Manufacturing System.  

Our company has been audited per the requirements of the Medical Device Single Audit Program (MDSAP).   

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