510(k) K223265
K223265 is an FDA 510(k) premarket notification submitted by Zhejiang Horizon Medical Technology Co., Ltd. for the device "CryoX Vitrification Freeze Kit / Thaw Kit". The FDA issued a decision of Substantially Equivalent on May 11, 2023. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Zhejiang Horizon Medical Technology Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2023
- Date Received
- October 24, 2022
- 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