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510(k) K781994

AUTOKERATOMETER, INSTRUMENT by Zeiss Humphrey System — Product Code HLQ

K781994 is an FDA 510(k) premarket notification submitted by Zeiss Humphrey System for the device "AUTOKERATOMETER, INSTRUMENT". The FDA issued a decision of Substantially Equivalent on February 12, 1979. The device falls under product code HLQ (Keratoscope, Ac-Powered), a Class I device regulated under 21 CFR 886.1350. Zeiss Humphrey System has at least 8 other 510(k) clearances on record.

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

Other clearances by Zeiss Humphrey System

  • K942439 — ZEISS OPMILAS 144 SURGICAL LASERS (July 1, 1994)
  • K923211 — DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE (November 8, 1993)
  • 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)

Other clearances for product code HLQ

  • K003299 — OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (March 9, 2001)
  • K973756 — EYE SYS VISTA (November 13, 1997)
  • K964290 — EYECHEK (January 9, 1997)
  • K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (January 31, 1995)
  • K944207 — TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 (December 7, 1994)
  • K944616 — KERATRON CORNEAL TOPOGRAPHER (November 22, 1994)
  • K940647 — ORBSCAN(TM) KERATOMETER (July 6, 1994)
  • K933556 — EH-270 CORNEAL TOPOGRAPHER (November 2, 1993)
  • K923435 — CORNEAL TOPOGRAPHY SYSTEM (February 16, 1993)
  • K922253 — KERATOREF L60 (June 19, 1992)

FDA data resources