Name: Predicase
Price: 199 USD

K-number	K240149
Device name	Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium
Applicant	Gimbo Medical Technology Shenzhen Co., Ltd.
Product code	MQL
Device class	Class II
Decision date	Jun 13, 2024
Decision	Substantially Equivalent
Regulation	884.6180

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium

Everything you need for a 510(k) submission. Nothing you don't.

Giftlife Fertilization Medium; Giftlife Cleavage Medium; Giftlife Blastocyst Medium; Giftlife Single Step Medium