K240605
- 510(k) number
- K240605
- Device name
- Ultra RapidWarm Blast
- Applicant
- Vitrolife Sweden AB SE
- Product code
- MQL — Media, Reproductive
- Decision date
- 2024-08-07
- Date received
- 2024-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240605.pdf
Official FDA record: K240605
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.