K232493
- 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. CN
- Product code
- MQG — Accessory, Assisted Reproduction
- Decision date
- 2024-05-07
- Date received
- 2023-08-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K232493.pdf
Official FDA record: K232493
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.