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510(k) K963762

CORNEAL TOPOGRAPHER 200 by Eclipse Ventures — Product Code MMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
September 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Topographer, Corneal, Ac-Powered
Device Class
Class I
Regulation Number
886.1350
Review Panel
OP
Submission Type

Other clearances for product code MMQ

  • K981665 — SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE (December 7, 1998)
  • K964702 — EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (May 20, 1997)
  • K964891 — ORBSHOT KERATOMETER (March 26, 1997)
  • K950077 — INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (June 14, 1995)