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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Monitoring, Perinatal
510(k) Number K231964
Device Name Novii+ Wireless Patch System
Applicant
Datex Ohmeda
9900 Innovation Drive
Wauwatosa,  WI  53226
Applicant Contact Isabel McGann
Correspondent
Datex Ohmeda
9900 Innovation Drive
Wauwatosa,  WI  53226
Correspondent Contact Isabel McGann
Regulation Number884.2740
Classification Product Code
HGM  
Date Received07/03/2023
Decision Date 12/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT03057275
Reviewed by Third Party No
Combination Product No
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