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, X-Ray, Angiographic
510(k) Number K993765
Device Name QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV)
Applicant
Medis Medical Imaging Systems BV
109 Danbury Rd.
Ridgefield,  CT  06877
Applicant Contact DOUGLAS F ORR
Correspondent
Medis Medical Imaging Systems BV
109 Danbury Rd.
Ridgefield,  CT  06877
Correspondent Contact DOUGLAS F ORR
Regulation Number892.1600
Classification Product Code
IZI  
Date Received11/08/1999
Decision Date 11/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-