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 Monitor, Line Isolation
510(k) Number K902492
Device Name CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S
Applicant
Datex Division Instrumentarium Corp.
P.O. Box 446
Sf-00101
Helsinki, Finland,  FI
Applicant Contact OLLI RIIKKALA
Correspondent
Datex Division Instrumentarium Corp.
P.O. Box 446
Sf-00101
Helsinki, Finland,  FI
Correspondent Contact OLLI RIIKKALA
Regulation Number870.2620
Classification Product Code
DRI  
Date Received06/05/1990
Decision Date 07/06/1990
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
-
-