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510(k) K945959

VIDEO VISION ANALYZER (VIVA), VRB 100 by Tomey Corporation USA — Product Code HKO

K945959 is an FDA 510(k) premarket notification submitted by Tomey Corporation USA for the device "VIDEO VISION ANALYZER (VIVA), VRB 100". The FDA issued a decision of Substantially Equivalent on March 1, 1995. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Tomey Corporation USA has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1995
Date Received
December 7, 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 Tomey Corporation USA

  • K971953 — CONFOSCAN (August 14, 1997)
  • K971685 — IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM (June 24, 1997)
  • K961805 — TOMEY DTL ELECTRODE (May 9, 1997)
  • K932571 — TOMEY PE-400 PORTABLE ERG & VEP WITH OPTIONAL PS-4 (August 31, 1995)
  • K944910 — TOMEY EM-1000 SPECULAR MICROSCOPE (November 22, 1994)
  • K924760 — TOMEY PROTON TONOMETER (April 5, 1993)
  • K921815 — TOMEY PE-300 PORTABLE ERG (July 15, 1992)
  • K912112 — PF-400,GF-300,IF-200,PG400,PG400C,AND ED-480 (June 17, 1991)

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

FDA data resources