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510(k) K944207

TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 by Computed Anatomy, Inc. — Product Code HLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 1994
Date Received
August 29, 1994
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 Computed Anatomy, Inc.

  • K902012 — VKS-1 VIDEO KERATOSCOPE (June 22, 1990)
  • K901363 — TOPOGRAPHIC MODELING SYSTEM (May 25, 1990)
  • K862379 — CORNEAL MODELING SYSTEM (August 25, 1986)

Other clearances for product code HLQ

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  • K973756 — EYE SYS VISTA (November 13, 1997)
  • K964290 — EYECHEK (January 9, 1997)
  • K945382 — TECHNOMED C-SCAN COLOR ELLIPSOID TOPOMETER (January 31, 1995)
  • 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)
  • K912740 — ACT-1 (ANTERIOR CORNEAL TOPOGRAPHER) (December 30, 1991)