FDA 510(k) Applications Submitted by DORIT WINITZ

FDA 510(k) Number Submission Date Device Name Applicant
K060146 01/19/2006 ACTIVECARE ++ SYSTEM MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
K060150 01/20/2006 SMARTSTEP SYSTEM/SMARSTEP CLINIC SYSTEM ANDANTE MEDICAL DEVICES LTD.
K070326 02/05/2007 NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM WIDEMED LTD
K070375 02/08/2007 EARLYSENSE ES-16 SYSTEM EARLYSENSE LTD.
K040591 03/08/2004 DUET SYSTEM BIOVIEW LTD.
K080836 03/25/2008 MODIFICATION TO ENDOFAST RELIANT SYSTEM ENDOGUN MEDICAL SYSTEMS
K050840 04/01/2005 MODIFICATION TO DUET SYSTEM BIOVIEW LTD.
K050856 04/05/2005 LCG (LIQUIDE CRYSTAL GLASSES) SYSTEM OPHTHOCARE LTD.
K021508 05/09/2002 OPUSDUO EC DENTAL LASER SYSTEM OPUSDENT LTD.
K061602 06/08/2006 DUET SYSTEM BIOVIEW LTD.
K231844 06/22/2023 ProMISÖ Fixation System Premia Spine Ltd.
K022415 07/24/2002 BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST WAISMED LTD.
K032519 08/15/2003 ENDO PAT 2000 ITAMAR MEDICAL
K041805 07/06/2004 MICROSCOPE SYSTEM MIRAS MIRROR IMAGING SOLUTIONS, LTD.


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