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510(k) K123208

DIGITAL RETINAL CAMERA by Canon Inc. -Medical Equipment Group — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2013
Date Received
October 12, 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

Other clearances by Canon Inc. -Medical Equipment Group

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  • K111682 — DIGITAL RADIOGRAPHY (September 2, 2011)
  • K112309 — DIGITAL RADIOGRAPHY (September 2, 2011)
  • K103591 — DIGITAL RADIOGRAPHY (March 29, 2011)
  • K102013 — DIGITAL RETINAL CAMERA (October 29, 2010)
  • K102012 — DIGITAL RADIOGRAPHY (August 17, 2010)

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