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 Embryo Image Assessment System, Assisted Reproduction
510(k) Number K250781
Device Name Embryo Predict
Applicant
Alife Health
16 Fayerweather St.
Cambridge,  MA  02138
Applicant Contact Melissa Teran
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number884.6195
Classification Product Code
PBH  
Date Received03/14/2025
Decision Date 05/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Clinical Trials NCT05483985
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-