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510(k) K923348

OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED by Zeiss Humphrey System — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1992
Date Received
May 28, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances by Zeiss Humphrey System

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  • K923211 — DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE (November 8, 1993)
  • 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)
  • K781994 — AUTOKERATOMETER, INSTRUMENT (February 12, 1979)
  • K782096 — INSTRUMENTS, OVERREFRACTION SYSTEM (January 26, 1979)

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