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 System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K191745
Device Name Medtronic Commander Flex
Applicant
Medtronic Care Management Services
7980 Century Blvd.
Chanhassan,  MN  55317
Applicant Contact Gordon Nelson
Correspondent
The Tamarack Group-Mpls, LLC
2584 Upton Ave. So
Minneapolis,  MN  55405
Correspondent Contact Charmaine Sutton
Regulation Number870.1130
Classification Product Code
DXN  
Subsequent Product Codes
DQA   DRG  
Date Received07/01/2019
Decision Date 05/15/2020
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
-
-