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Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213668
510(k) Type
Traditional
Applicant
GE Healthcare (GE Medical Systems, LLC)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/20/2022
Days to Decision
59 days
Submission Type
Summary