Welcome to Stethophone

You are currently viewing the US version of this website. The regulation of medical devices is specific to each country. This website contains information about products that may not be available in all countries, or may be available under different trademarks or for different indications and audiences.

Currently different versions of Stethophone are recognized as a medical device in the USA, Canada, and Ukraine. This means that Stethophone is available for residents of these countries. We are working on offering Stethophone in more countries in the future.

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Help Center

Is Stethophone Pro a medical device?

Updated

Stethophone Pro 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 Pro unique device identification:  

https://accessgudid.nlm.nih.gov/devices/00860011561729

Sparrow’s approach is based on providing the highest quality of our medical devices. Stethophone Pro 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 Pro 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).