CryoX Vitrification Freeze Kit / Thaw Kit— 510(k) K223265

Name: FDA 510(k) clearance K223265
Creator: U.S. Food and Drug Administration
Published: 2023-05-11

Substantially Equivalent

Zhejiang Horizon Medical Technology Co., Ltd.

FDA 510(k) clearance K223265 for CryoX Vitrification Freeze Kit / Thaw Kit, Substantially Equivalent on 2023-05-11. Applicant: Zhejiang Horizon Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Horizon Medical Technology Co., Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2022-10-24
Decision date: 2023-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiaxing, CN

Download summary PDF View on FDA.gov ↗

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