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 Oximeter
510(k) Number K083325
Device Name N-600X WITH SPD, OXIMAX N-600X
Applicant
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Applicant Contact SCOTT D DICKERHOFF
Correspondent
COVIDIEN
6135 GUNBARREL AVE.
BOULDER,  CO  80301
Correspondent Contact SCOTT D DICKERHOFF
Regulation Number870.2700
Classification Product Code
DQA  
Date Received11/12/2008
Decision Date 03/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Clinical Trials NCT00775346
Reviewed by Third Party No
Combination Product No
-
-