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XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233200
510(k) Type
Traditional
Applicant
Gemss Healthcare Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/16/2023
Days to Decision
49 days
Submission Type
Summary

XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K233200
510(k) Type
Traditional
Applicant
Gemss Healthcare Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
11/16/2023
Days to Decision
49 days
Submission Type
Summary