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 Analyzer, Nitric Oxide
510(k) Number K023014
Device Name VIANOX DELIVERY SYSTEM, MODEL I
Applicant
Pulmonox Medical, Inc.
10835-120th St.
Suite 200
Edmonton, Ab,  CA T5H 3P9
Applicant Contact PAULA TOMAT
Correspondent
Pulmonox Medical, Inc.
10835-120th St.
Suite 200
Edmonton, Ab,  CA T5H 3P9
Correspondent Contact PAULA TOMAT
Regulation Number868.2380
Classification Product Code
MRP  
Subsequent Product Codes
MRN   MRQ  
Date Received09/10/2002
Decision Date 08/14/2003
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
-
-