• 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 K121520
Model KN-9100
Device Name ULTRASONIC NEBULIZER (MESH TYPE)
Original Applicant
K-JUMP HEALTH CO., LTD.
no. 56, wu kung 5th rd.,
new taipei indust park
new taipei,  TW 24890
Original Contact jm lin
Regulation Number868.5630
Classification Product Code
CAF  
Date Received05/22/2012
Decision Date 03/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-