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Tuesday, 05/11/2021 7:52:00 AM

Tuesday, May 11, 2021 7:52:00 AM

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The FDA SRO is not FDA approval status list. It's a list of companies that sell products that are FDA regulated or anticipated to sell FDA regulated products. Because RMSL has already registered their third party CPAP machine that's listed on their website they are already on the list.

RMSL is always going to show up on the FDA SRO list because they have registered their branded third party cpap machine that has it's own 510k. It doesn't reflect the status of the DeltaWave mask in the 510k approval process.
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