K241341
- 510(k) number
- K241341
- Device name
- cryo-GO Vitrification Device
- Applicant
- Fujifilm Irvine Scientific CA · US
- Product code
- MQK — Labware, Assisted Reproduction
- Decision date
- 2024-09-26
- Date received
- 2024-05-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K241341.pdf
Official FDA record: K241341
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.