• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K121969
Model TD-7013/TD-7012
Device Name U-RIGHT COMPRESSOR NEBULIZER
Original Applicant
TAIDOC TECHNOLOGY CORPORATION
3f,5f, no.127, wugong 2nd rd.
wugu district
new taipei city,  TW 24888
Original Contact pinjung chen
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/05/2012
Decision Date 02/28/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-