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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
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