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510(k) K864012

IRAS PERIMETER by Randwal Instrument Co., Inc. — Product Code HPJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 1986
Date Received
October 15, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Visual Field, Laser
Device Class
Class II
Regulation Number
886.1360
Review Panel
OP
Submission Type

Other clearances by Randwal Instrument Co., Inc.

  • K873990 — IRAS EDS INTERFEROMETRIC STIMULATOR (February 5, 1988)
  • K873987 — IRAS GLARE TESTER (November 24, 1987)
  • K853556 — LASER IRAS (November 1, 1985)
  • K842567 — PORTABLE ACUIOMETER (August 15, 1984)
  • K827577 — VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER (January 24, 1983)

Other clearances for product code HPJ

  • K853556 — LASER IRAS (November 1, 1985)
  • K822415 — THE OCUPLOT D (September 7, 1982)
  • K813429 — LASER PHOTOCOAGULATOR ARGON MED. LASER (January 22, 1982)
  • K781507 — RETINOMETER (November 15, 1978)