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510(k) K143211

myVision Track Model 005 by Vital Art and Science Incorporated — Product Code HOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2015
Date Received
November 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Grid, Amsler
Device Class
Class I
Regulation Number
886.1330
Review Panel
OP
Submission Type

Other clearances by Vital Art and Science Incorporated

  • K121738 — MYVISIONTRACK(TM) (February 22, 2013)

Other clearances for product code HOQ

  • K180895 — Alleye (June 27, 2018)
  • K121738 — MYVISIONTRACK(TM) (February 22, 2013)
  • K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (March 4, 2002)
  • K874252 — KREDA DISC (January 27, 1988)
  • K863429 — MODIFIED DEVICE FOR SELF EXAMINATION OF EYES (January 20, 1987)
  • K843227 — MACULAR FUNCTION ANALYZER (July 22, 1985)
  • K843702 — APPARATUS & METHODS SELF-EXAM OF EYE (January 3, 1985)