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510(k) K890559

NIDEK AR-1200 by Nidek, Inc. — Product Code HKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1989
Date Received
February 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type

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  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K942242 — AUTO REF-KERATOMETER, RK-3 (September 2, 1994)
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  • K925304 — AUTOREF LENSMETER RL-10 (February 17, 1994)
  • K924741 — OPTEC 3000 (April 6, 1993)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)