• 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 embryo image assessment system, assisted reproduction
510(k) Number K182798
Device Name KIDScore D3
Applicant
Vitrolife A/S
Jens Juuls Vej 20
viby j,  DK 8260
Applicant Contact belinda dueholm
Correspondent
Vitrolife A/S
Jens Juuls Vej 20
viby j,  DK 8260
Correspondent Contact belinda dueholm
Regulation Number884.6195
Classification Product Code
PBH  
Date Received10/02/2018
Decision Date 07/19/2019
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
-
-