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SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163140
510(k) Type
Traditional
Applicant
GEMSS MEDICAL SYSTEMS CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/26/2017
Days to Decision
198 days
Submission Type
Summary

SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K163140
510(k) Type
Traditional
Applicant
GEMSS MEDICAL SYSTEMS CO., LTD
Country
South Korea
FDA Decision
Substantially Equivalent
Decision Date
5/26/2017
Days to Decision
198 days
Submission Type
Summary