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 K160718
Device Name Vital Sync Informatics Manager & Virtual Patient Monitoring Platform
Applicant
COVIDIEN
6135 Gunbarrel Avenue
Boulder,  CO  80301
Applicant Contact Timothy Holwick
Correspondent
COVIDIEN
6135 Gunbarrel Avenue
Boulder,  CO  80301
Correspondent Contact Timothy Holwick
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DXJ   OUG  
Date Received03/15/2016
Decision Date 11/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-