Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K252338
Device Name MySleepDash
Applicant
Somnetics International, Inc. (Dba Transcend Inc)
103 Osborne Rd. NE
Fridley,  MN  55432
Applicant Contact William Brown
Correspondent
Somnetics International, Inc. (Dba Transcend Inc)
103 Osborne Rd. NE
Fridley,  MN  55432
Correspondent Contact William Brown
Regulation Number868.5905
Classification Product Code
BZD  
Date Received07/28/2025
Decision Date 04/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-