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Remsleep Holdings Inc.’s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Remsleep Holdings Inc.’s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Tampa, FL, January 22, 2024 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) has received a response to the company’s 510(K) submission K233415. The agency has determined that additional information is required. The agency has asked for additional information regarding Administrative Information, Device Description, Substantial Equivalence (SE), Labeling, Biocompatibility, and...

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Remsleep Holdings Inc.’s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415)

Remsleep Holdings Inc.’s DeltaWave Mask Moves to Substantive Review of FDA 510k Process

Tampa, FL, November 2, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, is pleased to announce its DeltaWave mask has moved to the Substantive Review portion of the FDA 510k review process. Previously, the company voluntarily withdrew its 510k submission during the Acceptance Review portion after meeting with the FDA reviewer. The comments from the reviewer at the...

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RemSleep Holdings Inc. Announces Submission of DeltaWave Mask for FDA 510K Review

RemSleep Holdings Inc. Announces Submission of DeltaWave Mask for FDA 510K Review

Tampa, FL, October 6, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, announces it has submitted the DeltaWave mask to the FDA for 510K review. After a series of unfortunate and frustrating delays due to Covid, industry recalls, and 3rd party testing that required retesting certain tests, RemSleep is excited to announce it has submitted the DeltaWave mask for FDA...

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RemSleep Holdings Inc. Provides an Update on Funding and DeltaWave

RemSleep Holdings Inc. Provides an Update on Funding and DeltaWave

Tampa, FL, September 25, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, announces a new investor agreement and DeltaWave submission update. RemSleep recently entered into a Purchase Agreement with Janbella Group, LLC which was the subject of an 8K filling dated September 18th and will commence with the registration statement on Form S-1 to be filed by...

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RemSleep Holdings Inc. Provides an Update on Funding and DeltaWave

RemSleep Holdings Inc. Announces Completion of DeltaWave CPAP Mask Testing

Tampa, FL, September 1, 2023 - RemSleep Holdings Inc. (OTCQB: RMSL), a medical device manufacturer dedicated to forever changing the level of treatment provided to Obstructive Sleep Apnea (OSA) patients, provides an update on its testing protocol for 510K clearance of its DeltaWave CPAP Mask. RemSleep has completed the testing protocol for 510K clearance and all tests have successfully passed including the Cytotoxicity and MLA tests which were the subject of past issues requiring retesting....

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