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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K942771
Device Name RESPIEVENTS
Applicant
Non-Invasive Monitoring Systems, Inc.
1300 N. 17th St.
Suite 300
Arlington,  VA  22209
Applicant Contact MARISA COYLE
Correspondent
Non-Invasive Monitoring Systems, Inc.
1300 N. 17th St.
Suite 300
Arlington,  VA  22209
Correspondent Contact MARISA COYLE
Regulation Number870.1425
Classification Product Code
DQK  
Date Received06/13/1994
Decision Date 02/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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