FDA 510(k) Application Details - K080177

Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive

  More FDA Info for this Device
510(K) Number K080177
Device Name System, Measurement, Blood-Pressure, Non-Invasive
Applicant NIHON SEIMITSU SOKKI CO., LTD.
3F, 2-17-6 AKEBONO-CHO
TACHIKAWA- SHI 190-0012 JP
Other 510(k) Applications for this Company
Contact KOJI KOBO
Other 510(k) Applications for this Contact
Regulation Number 870.1130

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

  More FDA Info for this Product Code
Date Received 01/24/2008
Decision Date 05/09/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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