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OEC One

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172700
510(k) Type
Traditional
Applicant
GE HUALUN MEDICAL SYSTEMS CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/9/2017
Days to Decision
63 days
Submission Type
Summary

OEC One

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K172700
510(k) Type
Traditional
Applicant
GE HUALUN MEDICAL SYSTEMS CO., LTD.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
11/9/2017
Days to Decision
63 days
Submission Type
Summary