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Entropy Module, E-ENTROPY-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150298
510(k) Type
Traditional
Applicant
GE HEALTHCARE FILAND OY
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
11/12/2015
Days to Decision
279 days
Submission Type
Summary

Entropy Module, E-ENTROPY-01

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K150298
510(k) Type
Traditional
Applicant
GE HEALTHCARE FILAND OY
Country
Finland
FDA Decision
Substantially Equivalent
Decision Date
11/12/2015
Days to Decision
279 days
Submission Type
Summary