K240149
- 510(k) number
- K240149
- Device name
- Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium
- Applicant
- Gimbo Medical Technology Shenzhen Co., Ltd. CN
- Product code
- MQL — Media, Reproductive
- Decision date
- 2024-06-13
- Date received
- 2024-01-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240149
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.