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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 K130570
Device Name NEUROVISION MEDICAL MOTION SENSOR
Applicant
Neurovision Medical Products, Inc.
2225 Sperry Ave., Suite 1000
Ventura,  CA  93003
Applicant Contact CHRISTINE VERGELY
Correspondent
Neurovision Medical Products, Inc.
2225 Sperry Ave., Suite 1000
Ventura,  CA  93003
Correspondent Contact CHRISTINE VERGELY
Regulation Number868.2375
Classification Product Code
BZQ  
Date Received03/04/2013
Decision Date 12/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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