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 K160940
Device Name Masimo Disposable Transflectance Forehead Sensor
Applicant
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Applicant Contact Marguerite Thomlinson
Correspondent
Masimo Corporation
52 Discovery
Irvine,  CA  92618
Correspondent Contact Marguerite Thomlinson
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/04/2016
Decision Date 11/23/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-