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 Tube, Tracheostomy (W/Wo Connector)
510(k) Number K100480
Device Name ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
Applicant
VITALTEC CORPORATION
NO. 58, FU CHIUN STREET
HSIN CHU CITY,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
VITALTEC CORPORATION
NO. 58, FU CHIUN STREET
HSIN CHU CITY,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number868.5800
Classification Product Code
BTO  
Date Received02/18/2010
Decision Date 06/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-