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FDA 510(k), K160240, Perimeter Otis™ 1.0 Optical Coherence Tomography System
FDA 510(k), K160240, Perimeter Otis™ 1.0 Optical Coherence Tomography System
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510(K) Number: K160240
Device Name: Perimeter Otis™ 1.0 Optical Coherence Tomography System
Manufacturer: PERIMETER MEDICAL IMAGING, INC.
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 02/01/2016
Decision Date: 05/13/2016
Regulation Medical Specialty: Radiology
Device Name: Perimeter Otis™ 1.0 Optical Coherence Tomography System
Manufacturer: PERIMETER MEDICAL IMAGING, INC.
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 02/01/2016
Decision Date: 05/13/2016
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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