FDA 510(k) Application Details - K963575

Device Classification Name Analyzer, Body Composition

  More FDA Info for this Device
510(K) Number K963575
Device Name Analyzer, Body Composition
Applicant OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS, IL 60061 US
Other 510(k) Applications for this Company
Contact EDWARD SIEMENS
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 09/06/1996
Decision Date 06/13/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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