OTIS Optical Coherence Tomography SYstem— 510(k) K190404

Substantially Equivalent

Perimeter Medical Imaging, Inc.

FDA 510(k) clearance K190404 for OTIS Optical Coherence Tomography SYstem, Substantially Equivalent on 2019-03-26. Applicant: Perimeter Medical Imaging, Inc..

Clearance details

Applicant: Perimeter Medical Imaging, Inc.
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2019-02-19
Decision date: 2019-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, CA

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