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 K133951
Device Name SMARTTOUCH
Applicant
NEXUS6, LTD.
8 COMMERCE STREET
SUITE 205
AUCKLAND,  NZ 1010
Applicant Contact GARTH SUTHERLAND
Correspondent
NEXUS6, LTD.
8 COMMERCE STREET
SUITE 205
AUCKLAND,  NZ 1010
Correspondent Contact GARTH SUTHERLAND
Regulation Number868.5630
Classification Product Code
CAF  
Date Received12/23/2013
Decision Date 04/25/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-