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 K000186
Device Name DATEX-OHMEDA INOVENT DELIVERY SYSTEM
Applicant
DATEX-OHMEDA
PO BOX 7550
MADISON,  WI  53707
Applicant Contact DANIEL KOSEDNAR
Correspondent
DATEX-OHMEDA
PO BOX 7550
MADISON,  WI  53707
Correspondent Contact DANIEL KOSEDNAR
Regulation Number868.5165
Classification Product Code
MRN  
Subsequent Product Codes
MRO   MRP   MRQ  
Date Received01/14/2000
Decision Date 02/10/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-