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510(k) K863429

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

K863429 is an FDA 510(k) premarket notification submitted by Wheel Checkers for the device "MODIFIED DEVICE FOR SELF EXAMINATION OF EYES". The FDA issued a decision of Substantially Equivalent on January 20, 1987. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330. Wheel Checkers has at least 1 other 510(k) clearance on record.

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)

Other clearances for product code HOQ

  • K180895 — Alleye (June 27, 2018)
  • K143211 — myVision Track Model 005 (March 20, 2015)
  • K121738 — MYVISIONTRACK(TM) (February 22, 2013)
  • 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)

FDA data resources