K242684
- 510(k) number
- K242684
- Device name
- Harioculture TL-16 Time-lapse Incubator
- Applicant
- Hua Yue Medical Technology Co., Ltd. CN
- Product code
- MQG — Accessory, Assisted Reproduction
- Decision date
- 2025-05-22
- Date received
- 2024-09-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242684.pdf
Official FDA record: K242684
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.