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 Accessory, Assisted Reproduction
510(k) Number K232493
Device Name Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)
Applicant
Wuhan Huchuang Union Technology Co., Ltd.
Bldg. 10, #818 Gaoxin Ave.
Wuhan,  CN 430206
Applicant Contact Yuanyuan Zhan
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number884.6120
Classification Product Code
MQG  
Subsequent Product Codes
MQK   MTX  
Date Received08/17/2023
Decision Date 05/07/2024
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
Predetermined Change
Control Plan Authorized		 No
-
-