FDA 510(k) Application Details - K012194

Device Classification Name Blood Pressure Cuff

  More FDA Info for this Device
510(K) Number K012194
Device Name Blood Pressure Cuff
Applicant NIHON SEIMITSU SOKKI CO., LTD.
2508-13 NAKAGO
KOMOCHI-MURA, KITAGUNMA-GUN
GUNMA-KEN 377-0293 JP
Other 510(k) Applications for this Company
Regulation Number 870.1120

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

  More FDA Info for this Product Code
Date Received 07/13/2001
Decision Date 07/20/2001
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 Y
Expedited Review



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