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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Breathing Frequency
510(k) Number K903011
Device Name RESPITRACE PLUS, RESPIBANDS, AND RESPICENTRAL
Applicant
Non-Invasive Monitoring Systems, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact RODNEY MUNSEY
Correspondent
Non-Invasive Monitoring Systems, Inc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact RODNEY MUNSEY
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received07/09/1990
Decision Date 03/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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