FDA Issues Warning Letter Over APAPs
The agency cited unapproved modifications to the an auto-CPAP system imported into the United States and a failure to report a firmware correction for unexpected shutdowns.
The agency cited unapproved modifications to the an auto-CPAP system imported into the United States and a failure to report a firmware correction for unexpected shutdowns.
The new statements focus on a commitment to improving diagnostics and therapies for respiratory, sleep, and cardiac care.
React Health has entered into a distribution agreement with SleepRes LLC to provide SleepRes’ recently launched V-Com CPAP accessory with new React Health positive airway pressure orders in the United States.
The Luna G3 Auto BPAP is available with integrated heated tubing, cellular connectivity, and an algorithm that auto-adjusts pressure settings.
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