ChestPal Pro helps frontline healthcare providers to reliably detect crackles and wheezes - aiding diagnosis and patient management. ChestPal is ISO 13485 certified and complies with all applicable FDA requirements. We adhere to internationally recognized standards and rigorous testing practices to ensure safety and efficacy of our products. Including but not limited to standards governing electrical safety, electromagnetic compatibility, biocompatibility and software. ChestPal has designated HIPAA privacy and security compliance officers, policies, procedures, and technical measures to ensure the confidentiality, integrity, and availability of sensitive information. ChestPal has determined that the ChestPal Pro is exempt from the premarket notification requirement under section 510(k) of the Federal Food, Drug, and Cosmetic Act. For more information please see: https://chestpal.com/