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Youmagic FLM System (YM5-U1)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240857
510(k) Type
Traditional
Applicant
We Medical Technology (Wuxi) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/15/2025
Days to Decision
413 days
Submission Type
Summary

Youmagic FLM System (YM5-U1)

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240857
510(k) Type
Traditional
Applicant
We Medical Technology (Wuxi) Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/15/2025
Days to Decision
413 days
Submission Type
Summary