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 K090360
Device Name PHILIPS M3001A MULTI MEASUREMENT SERVER
Applicant
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Applicant Contact JENS-PETER SEHER
Correspondent
Philips Medizin Systeme Boblingen GmbH
Hewlett-Packard-Str. 2
Boeblingen,  DE D-71034
Correspondent Contact JENS-PETER SEHER
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Code
DPZ  
Date Received02/12/2009
Decision Date 05/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-