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510(k) K842567

PORTABLE ACUIOMETER by Randwal Instrument Co., Inc. — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1984
Date Received
July 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
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)
  • K864012 — IRAS PERIMETER (December 12, 1986)
  • K853556 — LASER IRAS (November 1, 1985)
  • K827577 — VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER (January 24, 1983)

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