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FDA 510(k) Application Details - K942852
Device Classification Name
Computer, Diagnostic, Programmable
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510(K) Number
K942852
Device Name
Computer, Diagnostic, Programmable
Applicant
NON-INVASIVE MONITORING SYSTEMS, INC.
1300 NORTH 17TH STREET, SUITE
300
ARLINGTON, VA 22209 US
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Contact
MARISA COYLE
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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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
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