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510(k) K050271

KOWA GENESIS-D HAND-HELD RETINAL CAMERA by Kowa Co. , Ltd. — Product Code HKI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 2005
Date Received
February 4, 2005
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 Kowa Co. , Ltd.

  • K133755 — KOWA SL-17 (March 11, 2014)
  • K112330 — KOWA VX-20 (February 16, 2012)
  • K101628 — KOWA NONMYD WX (January 26, 2011)
  • K091098 — KOWAGENESIS-DF (August 7, 2009)
  • K091039 — KOWA, FM-600, MODEL LSS50 (August 7, 2009)
  • K091683 — KOWA VX-10 A (July 2, 2009)
  • K083387 — MODIFICATION TO KOWA NONMYD ALPHA-DIII (January 16, 2009)
  • K082767 — KOWA NONMYD ALPHA-DIII (October 21, 2008)
  • K080681 — KOWA GENESIS-D (April 4, 2008)
  • K063640 — KOWA SL-15 (December 18, 2006)

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