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510(k) K102859

RETCAM 3 OPTHALMIC IMAGING SYSTEM by Clarity Medical Systems — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2011
Date Received
September 30, 2010
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

Other clearances by Clarity Medical Systems

  • K090326 — RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS (November 25, 2009)
  • K083771 — RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP (January 30, 2009)
  • K081858 — RETCAM 3 OPHTHALMIC IMAGING SYSTEM (November 5, 2008)

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