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 Over-The-Counter Device To Assess Risk Of Sleep Apnea
510(k) Number K261011
Device Name Sleep Apnea Feature (v2.0)
Applicant
Samsung Electronics Co., Ltd.
129 Samsung-Ro, Yeoungton-Gu
Suwon-Si,  KR
Applicant Contact Hon Pak
Correspondent
Samsung Research America, Inc.
665 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact Chaoyi Kang
Classification Product Code
QZW  
Date Received03/26/2026
Decision Date 07/20/2026
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		 Yes
-
-