Remsleep Holdings Inc.'s DeltaWave Mask has received questions from FDA regarding 510k submission (K233415) [Yahoo! Finance]
REMSLEEP HOLDINGS INC (RMSL)
NASDAQ:AMEX Investor Relations:
marketwired.com/press-release/remsleep-holdings-inc-announces-launch-of-new-corporate-website-otc-pink-bvigd-2006418.htm
Company Research
Source: Yahoo! Finance
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 Performance testing. All these questions can be answered, and we are in the process of responding with the answers. The agency has also requested additional Shelf-Life testing for DeltaWave packaging. We are in the process of initiating accelerated Shelf-Life testing for the DeltaWave packaging. This request was a surprise to us, but we will promptly comply. Remsleep CEO, Tom Wood, commented: “Investors want a 510(K) almost as much as Remsleep. We understand the frustration. Investors can be assured we will answer the questions from the agency, perform the additional tests required, and we will make every effort to gain
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News
- REMSleep Holdings Patent Status [Yahoo! Finance]Yahoo! Finance
- REMSleep Holdings Patent StatusGlobeNewswire
- REMSleep Holdings Shareholder Update [Yahoo! Finance]Yahoo! Finance
- REMSleep Holdings Shareholder UpdateGlobeNewswire
RMSL
Sec Filings
- 4/16/24 - Form 10-K
- 3/29/24 - Form NT
- 2/14/24 - Form 424B3
- RMSL's page on the SEC website