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
510(k) Number K990642
Device Name ECHOFLOW DOPPLER BLOOD VELOCITY METER
Applicant
Echocath, Inc.
4326 U.S. Rte. #1
Monmouth Junction,  NJ  08852
Applicant Contact GEPRGE MYERS
Correspondent
Echocath, Inc.
4326 U.S. Rte. #1
Monmouth Junction,  NJ  08852
Correspondent Contact GEPRGE MYERS
Regulation Number870.2880
Classification Product Code
JOP  
Date Received02/26/1999
Decision Date 09/16/1999
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
-
-