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 Transducer, Blood-Pressure, Extravascular
510(k) Number K120624
Device Name ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT)
Applicant
Elcam Medical Acal
M.P. Merom Ha'Galil
Kibbutz Baram,  IL 13860
Applicant Contact AHARON COHEN
Correspondent
Eleam Medical A.C.A.L
M.P. Merom Ha'Galil
Kibbutz Baram,  IL 13860
Correspondent Contact AHARON COHEN
Regulation Number870.2850
Classification Product Code
DRS  
Date Received03/01/2012
Decision Date 06/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-