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SIGNA Premier

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K193282
510(k) Type
Traditional
Applicant
GE Healthcare (GE Medical Systems, LLC)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/10/2020
Days to Decision
135 days
Submission Type
Summary