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Pristina Serena Bright

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193334
510(k) Type
Traditional
Applicant
GE Healthcare
Country
France
FDA Decision
Substantially Equivalent
Decision Date
5/15/2020
Days to Decision
165 days
Submission Type
Summary

Pristina Serena Bright

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193334
510(k) Type
Traditional
Applicant
GE Healthcare
Country
France
FDA Decision
Substantially Equivalent
Decision Date
5/15/2020
Days to Decision
165 days
Submission Type
Summary