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510(k) K123460

TRC-NW300 NON-MYDRIATIC RETINAL CAMERA by Topcon Medical Systems, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2013
Date Received
November 9, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, Ophthalmic, Ac-Powered
Device Class
Class II
Regulation Number
886.1120
Review Panel
OP
Submission Type

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  • K110489 — SLIT LAMP SL-2G (May 23, 2011)
  • K093313 — SYNERGY (December 2, 2009)
  • K083316 — 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM (March 13, 2009)
  • K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINA (January 13, 2009)
  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)

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