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510(k) K873990

IRAS EDS INTERFEROMETRIC STIMULATOR by Randwal Instrument Co., Inc. — Product Code HLX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1988
Date Received
October 1, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photostimulator, Ac-Powered
Device Class
Class II
Regulation Number
886.1630
Review Panel
OP
Submission Type

Other clearances by Randwal Instrument Co., Inc.

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  • K853556 — LASER IRAS (November 1, 1985)
  • K842567 — PORTABLE ACUIOMETER (August 15, 1984)
  • K827577 — VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER (January 24, 1983)

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