FDA 510(k) Application Details - K942771

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K942771
Device Name	Computer, Diagnostic, Programmable
Applicant	NON-INVASIVE MONITORING SYSTEMS, INC. 1300 NORTH 17TH STREET, SUITE 300 ARLINGTON, VA 22209 US Other 510(k) Applications for this Company
Contact	MARISA COYLE 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	06/13/1994
Decision Date	02/13/1996
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	N
Expedited Review