FDA 510(k) Application Details - K053556

Device Classification Name Analyzer, Body Composition

  More FDA Info for this Device
510(K) Number K053556
Device Name Analyzer, Body Composition
Applicant JAWON MEDICAL CO., LTD.
ROOM 624, LIFE OFFICETEL, 61-3
YOIDO-DONG, YOUNGDEUNGPO-GU
SEOUL, KOREA 150-731 KR
Other 510(k) Applications for this Company
Contact HEUNG BONG LIM
Other 510(k) Applications for this Contact
Regulation Number 870.2770

  More FDA Info for this Regulation Number
Classification Product Code MNW
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/20/2005
Decision Date 08/31/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact