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FDA Issues Warning Letter Over APAPs
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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. Key takeaways: The FDA issued a warning letter to BMC Medical regarding G3X APAP and Luna G3 APAP devices imported to the United States by React Health. The agency states the G3X APAP requires a new 510(k) clearance due to significant design, material, and firmware modificat…
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