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510(k) K031629

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI by Canon USA, Inc. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2003
Date Received
May 27, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 USA, Inc.

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  • K023750 — CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G (November 22, 2002)
  • K023586 — DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS (November 5, 2002)
  • K003689 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31 (January 2, 2002)
  • K992606 — CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 (June 21, 2000)
  • K992547 — CANON X-RAY DIGITAL CAMERA, MODEL CXDI-22 (October 13, 1999)
  • K981556 — CANON X-RAY DIGITAL CAMERA CXDI-11 (November 4, 1998)
  • K980246 — NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM (May 6, 1998)

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