Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium— 510(k) K240149

Name: FDA 510(k) clearance K240149
Creator: U.S. Food and Drug Administration
Published: 2024-06-13

Substantially Equivalent

Gimbo Medical Technology Shenzhen Co., Ltd.

FDA 510(k) clearance K240149 for Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium, Substantially Equivalent on 2024-06-13. Applicant: Gimbo Medical Technology Shenzhen Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gimbo Medical Technology Shenzhen Co., Ltd.
Product code: Code MQL
Device class: Class 2
Regulation: 21 CFR 884.6180
Advisory panel: Obstetrics/Gynecology
Date received: 2024-01-19
Decision date: 2024-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Gimbo Medical Technology Shenzhen Co., Ltd.

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Data sourced from openFDA. This site is unofficial and independent of the FDA.