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 Ventilatory Effort Recorder
510(k) Number K222579
Device Name Belun Sleep System BLS-100
Applicant
Belun Technology Company Limited
Unit 218, 2/F, Core Building 2, No. 1 Science Park
West Avenue, Hong Kong Science Park
Sha Tin,  CN
Applicant Contact Leung Lap Wai Lydia
Correspondent
Belun Technology Company Limited
Unit 218, 2/F, Core Building 2, No. 1 Science Park
West Avenue, Hong Kong Science Park
Sha Tin,  CN
Correspondent Contact Leung Lap Wai Lydia
Regulation Number868.2375
Classification Product Code
MNR  
Date Received08/25/2022
Decision Date 02/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT04885062
Reviewed by Third Party No
Combination Product No
-
-