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, Hemodialysis, Access Recirculation Monitoring
510(k) Number K021571
Device Name TRANSONIC FLOW-QC SET MODEL ADT1010
Applicant
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Applicant Contact MARK S ALSBERGE
Correspondent
Transonic Systems, Inc.
34 Dutch Mill Rd.
Ithaca,  NY  14850
Correspondent Contact MARK S ALSBERGE
Regulation Number876.5820
Classification Product Code
MQS  
Date Received05/14/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-