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DHX-70H, XTG-70H

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221587
510(k) Type
Traditional
Applicant
DIGIMED Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
3/3/2023
Days to Decision
275 days
Submission Type
Summary

DHX-70H, XTG-70H

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K221587
510(k) Type
Traditional
Applicant
DIGIMED Co., Ltd.
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
3/3/2023
Days to Decision
275 days
Submission Type
Summary