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OTIS Optical Coherence Tomography SYstem

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190404
510(k) Type
Traditional
Applicant
Perimeter Medical Imaging, Inc.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/26/2019
Days to Decision
35 days
Submission Type
Summary

OTIS Optical Coherence Tomography SYstem

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190404
510(k) Type
Traditional
Applicant
Perimeter Medical Imaging, Inc.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
3/26/2019
Days to Decision
35 days
Submission Type
Summary