FDA 510(k) Application Details - K012444

Device Classification Name	Blood Pressure Cuff   More FDA Info for this Device
510(K) Number	K012444
Device Name	Blood Pressure Cuff
Applicant	PT. SUGIH INSTRUMENDO ABADI 933A MOTOR PKWY. HAUPPAUGE, NY 11788 US Other 510(k) Applications for this Company
Contact	RICHARD GRAVER Other 510(k) Applications for this Contact
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	08/01/2001
Decision Date	08/16/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review