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 computer, diagnostic, programmable
510(k) Number K223127
Device Name HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
Applicant
Edwards Lifeciences, LLC
1 Edwards Way
Irvine,  CA  92614
Applicant Contact Michelle Ducca
Correspondent
Edwards Lifeciences, LLC
1 Edwards Way
Irvine,  CA  92614
Correspondent Contact Michelle Ducca
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Codes
DQE   DSB   DXN   MUD   QAQ  
QMS  
Date Received10/03/2022
Decision Date 11/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-