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510(k) K802029

OBJECTIVE REFRACTOR by Zeiss Humphrey System — Product Code HKO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
August 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Refractometer, Ophthalmic
Device Class
Class I
Regulation Number
886.1760
Review Panel
OP
Submission Type

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  • K923348 — OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED (December 10, 1992)
  • K852639 — HUMPHREY FIELD ANALYZER MODEL 630 (September 18, 1985)
  • K852638 — HUMPHREY IMAGE ANALYZER MODEL 110 (August 12, 1985)
  • K821940 — THE HUMPHREY FIELD ANALYZER MODEL 610 (July 28, 1982)
  • K781994 — AUTOKERATOMETER, INSTRUMENT (February 12, 1979)
  • K782096 — INSTRUMENTS, OVERREFRACTION SYSTEM (January 26, 1979)

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