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 System, Test, Breath Nitric Oxide
510(k) Number K170983
Device Name NIOX VERO
Applicant
Circassia AB
Hanselligatan 13
Uppsala,  SE se-754 50
Applicant Contact Susanne Parks
Correspondent
Circassia AB
Hanselligatan 13
Uppsala,  SE se-754 50
Correspondent Contact William Sammons
Regulation Number862.3080
Classification Product Code
MXA  
Date Received04/03/2017
Decision Date 11/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-