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510(k) K781994

AUTOKERATOMETER, INSTRUMENT by Zeiss Humphrey System — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1979
Date Received
November 29, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Keratoscope, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
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)
  • K802029 — OBJECTIVE REFRACTOR (November 12, 1980)
  • K782096 — INSTRUMENTS, OVERREFRACTION SYSTEM (January 26, 1979)

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