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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 K904396
Device Name SIMPLEX NEONATAL BREATHING CIRCUIT SYSTEM
Applicant
SIMPLEX MEDICAL SYSTEMS, INC.
3305 SPRINGMOUNTAIN ROAD, #60
LAS VEGAS,  NV  89102
Applicant Contact JAMES WEIGL
Correspondent
SIMPLEX MEDICAL SYSTEMS, INC.
3305 SPRINGMOUNTAIN ROAD, #60
LAS VEGAS,  NV  89102
Correspondent Contact JAMES WEIGL
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received09/25/1990
Decision Date 03/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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