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 Uterine Electromyographic Monitor
510(k) Number K140862
Device Name MONICA NOVII WIRELESS PATCH SYSTEM
Applicant
MONICA HEALTHCARE LTD.
BIOCITY, PENNYFOOT STREET
NOTTINGHAM,  GB NG1 1GF
Applicant Contact CARL BARRATT
Correspondent
MONICA HEALTHCARE LTD.
BIOCITY, PENNYFOOT STREET
NOTTINGHAM,  GB NG1 1GF
Correspondent Contact CARL BARRATT
Regulation Number884.2720
Classification Product Code
OSP  
Date Received04/03/2014
Decision Date 08/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Clinical Trials NCT01889316
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-