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510(k) K843227

MACULAR FUNCTION ANALYZER by Danek Medical, Inc. — Product Code HOQ

K843227 is an FDA 510(k) premarket notification submitted by Danek Medical, Inc. for the device "MACULAR FUNCTION ANALYZER". The FDA issued a decision of Substantially Equivalent on July 22, 1985. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330. Danek Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1985
Date Received
August 16, 1984
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 Danek Medical, Inc.

  • K994122 — BONE GRAFT WASHER, MODEL 9090114 - 9090118 (February 18, 2000)
  • K993810 — CD HORIZON SPINAL SYSTEM (February 3, 2000)
  • K993855 — ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM (December 15, 1999)
  • K991528 — MODIFICATION TO TENOR SPINAL SYSTEM-ROD/BOLT CONNECTOR (May 28, 1999)
  • K990603 — MODIFICATION OF THE ZPLATE-ATL ANTERIOR FIXATION SYSTEM (March 10, 1999)
  • K982875 — MODIFICATION TO ZPLATE-ATL ANTERIOR FIXATION SYSTEM (January 19, 1999)
  • K984522 — MODIFICATION OF TSRH SPINAL SYSTEM (January 6, 1999)
  • K982154 — MODIFICATION OF TOWNLEY PEDICLE SCREW PLATING SYSTEM (July 13, 1998)
  • K970599 — TOWNLEY PEDICLE SCREW PLATING SYSTEM (March 20, 1998)
  • K943827 — SPINE FIXATION (February 14, 1996)

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)
  • K863429 — MODIFIED DEVICE FOR SELF EXAMINATION OF EYES (January 20, 1987)
  • K843702 — APPARATUS & METHODS SELF-EXAM OF EYE (January 3, 1985)

FDA data resources