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 Device, Counter-Pulsating, External
510(k) Number K940264
Device Name VASOGENICS EECP-MC2
Applicant
Vasogenics, Inc.
38 Market St.
Port Jefferson Station,  NY  11776
Applicant Contact JOHN C.K. HUI, PH.D.
Correspondent
Vasogenics, Inc.
38 Market St.
Port Jefferson Station,  NY  11776
Correspondent Contact JOHN C.K. HUI, PH.D.
Regulation Number870.5225
Classification Product Code
DRN  
Date Received01/21/1994
Decision Date 02/23/1995
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
-
-