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510(k) K863429

MODIFIED DEVICE FOR SELF EXAMINATION OF EYES by Wheel Checkers — Product Code HOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1987
Date Received
September 4, 1986
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 Wheel Checkers

  • K843702 — APPARATUS & METHODS SELF-EXAM OF EYE (January 3, 1985)

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  • K014044 — MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT) (March 4, 2002)
  • K874252 — KREDA DISC (January 27, 1988)
  • K843227 — MACULAR FUNCTION ANALYZER (July 22, 1985)
  • K843702 — APPARATUS & METHODS SELF-EXAM OF EYE (January 3, 1985)