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 K081870
Device Name MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
Applicant
GE HealthCare Finland OY
8200 W. Tower Ave.
Milwaukee,  WI  53223
Applicant Contact JOHN PENDERGAST
Correspondent
GE HealthCare Finland OY
8200 W. Tower Ave.
Milwaukee,  WI  53223
Correspondent Contact JOHN PENDERGAST
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/01/2008
Decision Date 07/31/2008
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
-
-