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Ilumien Optis, Optis Integrated, Optis Mobile

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183320
510(k) Type
Traditional
Applicant
St. Jude Medical (now Abbott Medical)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/2/2019
Days to Decision
123 days
Submission Type
Summary

Ilumien Optis, Optis Integrated, Optis Mobile

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K183320
510(k) Type
Traditional
Applicant
St. Jude Medical (now Abbott Medical)
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/2/2019
Days to Decision
123 days
Submission Type
Summary