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 K896437
Device Name KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM
Applicant
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Applicant Contact DAVID CROMWICK
Correspondent
Kontron Instruments, Inc.
9 Plymouth St.
Everett,  MA  02149
Correspondent Contact DAVID CROMWICK
Regulation Number870.2120
Classification Product Code
DPT  
Date Received11/09/1989
Decision Date 12/03/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-