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 K133105
Device Name BREEZE NEBULIZER (NBR-10X)
Applicant
DIGIO2 INTERNATIONAL CO., LTD
NO,45, MINSHENG RD, DANSHUI TOWN
NEW TAIPEI CITY,  TW 251
Applicant Contact MICHAEL LEE
Correspondent
DIGIO2 INTERNATIONAL CO., LTD
NO,45, MINSHENG RD, DANSHUI TOWN
NEW TAIPEI CITY,  TW 251
Correspondent Contact MICHAEL LEE
Regulation Number868.5630
Classification Product Code
CAF  
Date Received09/30/2013
Decision Date 06/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-