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510(k) K964891

ORBSHOT KERATOMETER by Orbtek, Inc. — Product Code MMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 1997
Date Received
December 6, 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 by Orbtek, Inc.

  • K940647 — ORBSCAN(TM) KERATOMETER (July 6, 1994)

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)
  • K963762 — CORNEAL TOPOGRAPHER 200 (December 23, 1996)
  • K950077 — INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (June 14, 1995)