• 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 K121770
Model HP-2167
Device Name HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER
Original Applicant
HEADSTAR MEDICAL PRODUCTS CO., LTD
9 f., no. 8, sec. 1,
chung-shan road, hsin-chang
city, taipei county,  TW 242
Original Contact gloria chen
Regulation Number868.5630
Classification Product Code
CAF  
Date Received06/15/2012
Decision Date 04/17/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-