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 Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K926233
Device Name CARDIO2 CYCLE
Applicant
Ergometrix, Inc.
Constance G. Bundy
6470 Riverview Ter.
Minneapolis,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Ergometrix, Inc.
Constance G. Bundy
6470 Riverview Ter.
Minneapolis,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number870.4200
Classification Product Code
KRI  
Date Received12/11/1992
Decision Date 06/04/1993
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
-
-