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Perimeter Otis™ 1.0 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
K160240
510(k) Type
Traditional
Applicant
PERIMETER MEDICAL IMAGING, INC.
Country
Canada
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
5/13/2016
Days to Decision
102 days
Submission Type
Summary

Perimeter Otis™ 1.0 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
K160240
510(k) Type
Traditional
Applicant
PERIMETER MEDICAL IMAGING, INC.
Country
Canada
FDA Decision
Substantially Equivalent - With Limitations
Decision Date
5/13/2016
Days to Decision
102 days
Submission Type
Summary