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 K053490
Device Name MERITS HEALTH PRODUCTS PORTABLE NEBULIZER
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG,  TW 407
Applicant Contact STEVE CHAO
Correspondent
MERITS HEALTH PRODUCTS CO., LTD.
9, ROAD 36
TAICHUNG INDUSTRIAL PARK
TAICHUNG,  TW 407
Correspondent Contact STEVE CHAO
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/15/2005
Decision Date 07/24/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
-
-