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510(k) K923211

DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE by Zeiss Humphrey System — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1993
Date Received
July 1, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Zeiss Humphrey System

  • K942439 — ZEISS OPMILAS 144 SURGICAL LASERS (July 1, 1994)
  • 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)
  • K781994 — AUTOKERATOMETER, INSTRUMENT (February 12, 1979)
  • K782096 — INSTRUMENTS, OVERREFRACTION SYSTEM (January 26, 1979)

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