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510(k) K942242

AUTO REF-KERATOMETER, RK-3 by Cannon U.S.A., Inc. — Product Code HKO

K942242 is an FDA 510(k) premarket notification submitted by Cannon U.S.A., Inc. for the device "AUTO REF-KERATOMETER, RK-3". The FDA issued a decision of Substantially Equivalent on September 2, 1994. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Cannon U.S.A., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1994
Date Received
May 9, 1994
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 Cannon U.S.A., Inc.

  • K960839 — FILM SCANNER 300 (December 18, 1996)

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)
  • 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)
  • K904828 — OPTEC 2300 AFVT, ARMED FORCES VISION TESTER (January 18, 1991)

FDA data resources