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 Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
510(k) Number K232580
Device Name Disposable Endobronchial Blocker Tube
Applicant
Shenzhen Insighters Medical Technology Co., Ltd.
The 13th Floor Of Hengtemei Bldg., Ganli Rd. #3
Shenzhen,  CN 518000
Applicant Contact Bonnie Fang
Correspondent
Shenzhen Insighters Medical Technology Co., Ltd.
The 13th Floor Of Hengtemei Bldg., Ganli Rd. #3
Shenzhen,  CN 518000
Correspondent Contact Kevin Huang
Regulation Number868.5740
Classification Product Code
CBI  
Date Received08/25/2023
Decision Date 12/14/2023
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
-
-