510(k) K233846
K233846 is an FDA 510(k) premarket notification submitted by Ecmpc, LLC for the device "Vitrification Solution Set and Warming Solution Set". The FDA issued a decision of Substantially Equivalent on August 27, 2024. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2024
- Date Received
- December 4, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type