Stethophone

The Stethophone is designed for both single-use and reusable applications, depending on the specific model variant. The manufacturer, Sparrow Acoustics, explicitly notes this flexibility in its description, so users should confirm the intended use (single-use or reusable) based on the variant they purchase. Reusable models would require proper cleaning and maintenance per manufacturer guidelines.

The Stethophone is an electronic stethoscope that connects to smartphones, enabling high-fidelity audio transmission for remote auscultation. This feature allows clinicians to share medical-grade sound data securely with specialists or colleagues, facilitating collaborative diagnosis while maintaining clinical accuracy as intended by the device’s design.

The Stethophone received FDA 510(k) clearance (K231551) under the traditional review pathway, with a decision classification of *Substantially Equivalent* to a predicate device. This means the FDA determined it meets regulatory standards for cardiovascular diagnostics as a Class II medical device, ensuring its safety and effectiveness for capturing and transmitting cardiac/pulmonary sounds in clinical settings.

The Stethophone comes in multiple variants, as indicated by the extensive list of registration numbers (e.g., 3013557562, 3010399798) under its OpenFDA entry. While exact specifications (e.g., earpiece size, tubing length) aren’t detailed here, the device is categorized under product code DQD for electronic stethoscopes. Contact Sparrow Acoustics directly or refer to their product documentation to match the variant to your clinical requirements (e.g., pediatric vs. adult use).