Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Monitoring, Perinatal
510(k) Number K254036
Device Name Novii+ Wireless Patch System
Applicant
Datex Ohmeda, Inc.
3114 N Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Shiwani Zalpuri
Correspondent
Datex Ohmeda, Inc.
3114 N Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Shiwani Zalpuri
Regulation Number884.2740
Classification Product Code
HGM  
Date Received12/16/2025
Decision Date 08/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-