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 Transducer, Ultrasonic, Diagnostic
510(k) Number K002958
Device Name SHAPEABLE DOPPLER FLOW PROBE
Applicant
Cook Vascular, Inc.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656 -0529
Applicant Contact THOMAS J KARDOS
Correspondent
Cook Vascular, Inc.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656 -0529
Correspondent Contact THOMAS J KARDOS
Regulation Number892.1570
Classification Product Code
ITX  
Date Received09/22/2000
Decision Date 12/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-