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510(k) K882191

NIDEK ARK-2000 by Nidek, Inc. — Product Code HKO

K882191 is an FDA 510(k) premarket notification submitted by Nidek, Inc. for the device "NIDEK ARK-2000". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Nidek, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1988
Date Received
May 24, 1988
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

Other clearances by Nidek, Inc.

  • K050336 — OPD-STATION SOFTWARE (August 24, 2005)
  • K042785 — MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 (December 14, 2004)
  • K031733 — NON-CONTACT TONOMETER, MODEL NT-4000 (December 4, 2003)
  • K032085 — GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000 (October 3, 2003)
  • K013694 — NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) (November 19, 2002)
  • K020876 — ECHOSCAN, MODEL US-1800 (May 3, 2002)
  • K014274 — NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 (April 17, 2002)
  • K013760 — DC-3300 LASER DIODE PHOTOCOAGULATOR (February 11, 2002)
  • K013864 — MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60 (February 8, 2002)
  • K990119 — EPI-STAR SURGICAL LASER SYSTER (July 27, 2000)

Other clearances for product code HKO

  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)
  • K000327 — WAVESCAN WAVEFRONT SYSTEM MODEL HS 1 (May 2, 2000)
  • K951179 — DIGITAL RETINOSCOPIC PHOTOMETER (May 30, 1995)
  • K945959 — VIDEO VISION ANALYZER (VIVA), VRB 100 (March 1, 1995)
  • K942242 — AUTO REF-KERATOMETER, RK-3 (September 2, 1994)
  • K940516 — AUTO REFF-30 (July 12, 1994)
  • K925304 — AUTOREF LENSMETER RL-10 (February 17, 1994)
  • K924741 — OPTEC 3000 (April 6, 1993)
  • K924778 — BURTON AUTO REFRACTOR/KERATOMETER - MODEL BARK-8 (April 5, 1993)
  • K924790 — BURTON AUTO REFRACTOR - MODEL BAR-7 (April 5, 1993)

FDA data resources