Brief: Remsleep Holdings's Deltawave Mask Has Received Questions From FDA Regarding 510K Submission (K233415)

REMSleep Holdings

22/01/2024 16:09

Jan 22 (Reuters) - REMSleep Holdings Inc  RMSL.PK :
    * REMSLEEP HOLDINGS INC.'S DELTAWAVE MASK HAS RECEIVED
QUESTIONS
FROM FDA REGARDING 510K SUBMISSION (K233415)
    * REMSLEEP HOLDINGS INC: AGENCY HAS DETERMINED THAT
ADDITIONAL
INFORMATION IS REQUIRED
    * REMSLEEP HOLDINGS INC - AGENCY HAS ALSO REQUESTED
ADDITIONAL
SHELF-LIFE TESTING FOR DELTAWAVE PACKAGING
    * REMSLEEP HOLDINGS INC - IN PROCESS OF INITIATING
ACCELERATED
SHELF-LIFE TESTING FOR DELTAWAVE PACKAGING
    * REMSLEEP HOLDINGS INC - HAS APPLIED FOR A GOVERNMENT GRANT
TO
PERFORM CLINICAL TRIALS ONCE 510(K) SUBMISSION HAS BEEN APPROVED
    * REMSLEEP HOLDINGS INC - HAS BEEN ALLOWED A NEW US PATENT
FOR
DELTAWAVE PRODUCT
    * REMSLEEP: FDA HAS ASKED FOR ADDITIONAL INFORMATION ON
ADMINISTRATIVE INFORMATION, DEVICE DESCRIPTION, SUBSTANTIAL
EQUIVALENCE, LABELING, ETC

Source text for Eikon:  urn:newsml:reuters.com:*:nGNX7jhktG
Further company coverage:  RMSL.PK 

 ((Reuters.Briefs@thomsonreuters.com;))