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510(k) K936205

COMPREHENSIVE PHOROPTER, MDR-680 by Canon USA, Inc. — Product Code HKN

K936205 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "COMPREHENSIVE PHOROPTER, MDR-680". The FDA issued a decision of Substantially Equivalent on September 28, 1994. The device falls under product code HKN (Refractor, Manual, Non-Powered, Including Phoropter), a Class I device regulated under 21 CFR 886.1770. Canon USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1994
Date Received
December 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractor, Manual, Non-Powered, Including Phoropter
Device Class
Class I
Regulation Number
886.1770
Review Panel
OP
Submission Type

Other clearances by Canon USA, Inc.

  • K090623 — DIGITAL RADIOGRAPHY CXDI-40G COMPACT (March 24, 2009)
  • K033624 — PACS SOFTWARE SOLUTION 2003 (December 15, 2003)
  • K031633 — CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C (June 11, 2003)
  • K031629 — CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI (June 6, 2003)
  • 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)

Other clearances for product code HKN

  • K874900 — WOODLYN CLASSIC REFRACTOR, PHOROPTOR (December 23, 1987)
  • K782118 — FUL-VUE (January 26, 1979)

FDA data resources