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 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
510(k) Number K171121
Device Name Masimo Root Monitoring System and Accessories
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 Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   CAT   CBQ   CBR   CBS  
CCK   CCL   DPZ   DQA   DXN   FLL  
GWQ   GXY   NHO   NHP   NHQ   OLT  
OLW   OMC   ORT  
Date Received04/17/2017
Decision Date 11/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-