DRI OCT Triton— 510(k) K173119
Substantially EquivalentTopcon Corporation
FDA 510(k) clearance K173119 for DRI OCT Triton, Substantially Equivalent on 2018-01-19. Applicant: Topcon Corporation. Device class: 2.
Clearance details
- Applicant
- Topcon Corporation
- Product code
- Code OBO
- Device class
- Class 2
- Regulation
- 21 CFR 886.1570
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tokyo, JP
Recent devices under product code OBO
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- K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
- K232828 — IMAGEnet6 Ophthalmic Data System
- K231222 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Data sourced from openFDA. This site is unofficial and independent of the FDA.