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 Apparatus, Nitric Oxide Delivery
510(k) Number K131686
Device Name INOMAX DSIR (DELIVERY SYSTEM)
Applicant
Ino Therapeutics/Ikaria
2902 Dairy Dr.
Madison,  WI  53718
Applicant Contact ROBERT BOVY
Correspondent
Ino Therapeutics/Ikaria
2902 Dairy Dr.
Madison,  WI  53718
Correspondent Contact ROBERT BOVY
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRP   MRQ  
Date Received06/10/2013
Decision Date 11/29/2013
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
Recalls CDRH Recalls
-
-