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 flowmeter, blood, cardiovascular
510(k) Number K112657
Device Name AUREFLO MONITORING SYSTEM
Applicant
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Applicant Contact DAVID KLEMENTOWSKI
Correspondent
TRANSONIC SYSTEMS, INC.
34 DUTCH MILL RD.
ITHACA,  NY  14850
Correspondent Contact DAVID KLEMENTOWSKI
Regulation Number870.2100
Classification Product Code
DPW  
Date Received09/13/2011
Decision Date 12/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-