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 Nebulizer (Direct Patient Interface)
510(k) Number K150591
Device Name Besmed Reusable Jet Nebulizer
Applicant
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW 24888
Applicant Contact WINNIE CHUNG
Correspondent
BESMED HEALTH BUSINESS CORP.
NO.5, LANE116, WU-KONG 2ND RD
NEW TAIPEI CITY,  TW 24888
Correspondent Contact PAUL DRYDEN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received03/09/2015
Decision Date 06/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-