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 K031370
Device Name SHINMED MODE SW-988 UNTRASONIC NEBULIZER
Applicant
SHINING WORLD HEALTH CARE CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Applicant Contact JEN KE-MIN
Correspondent
SHINING WORLD HEALTH CARE CO., LTD.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 300
Correspondent Contact JEN KE-MIN
Regulation Number868.5630
Classification Product Code
CAF  
Date Received04/30/2003
Decision Date 09/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-