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 Probe, Blood-Flow, Extravascular
510(k) Number K133903
Device Name BIO-PROBE TRANSDUCER (ADULT)
Applicant
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Applicant Contact RAHUL SHAH
Correspondent
Medtronic, Inc.
8200 Coral Sea St. NE
Mounds View,  MN  55112
Correspondent Contact RAHUL SHAH
Regulation Number870.2120
Classification Product Code
DPT  
Date Received12/20/2013
Decision Date 04/10/2014
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
-
-