• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name system, monitoring, perinatal
510(k) Number K121758
Device Name CERNER FETALINK+(VERSION1.0)
Original Applicant
CERNER CORP.
10234 marion park drive
kansas city,  MO  64137
Original Contact shelley s looby
Regulation Number884.2740
Classification Product Code
HGM  
Date Received06/15/2012
Decision Date 10/09/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-