FDA 510(k) Application Details - K012020

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K012020
Device Name	Computer, Diagnostic, Programmable
Applicant	NON-INVASIVE MONITORING SYSTEMS, INC. 1840 WEST AVE. MIAMI BEACH, FL 33139 US Other 510(k) Applications for this Company
Contact	ALLAN F BRACK Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2001
Decision Date	08/21/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review