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510(k) K061674

RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER by Talia Technology , Ltd. — Product Code HLI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2006
Date Received
June 14, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Ac-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type

Other clearances by Talia Technology , Ltd.

  • K041290 — RTA MODEL D RETINAL THICKNESS ANALYZER (May 24, 2004)
  • K031312 — RTA MODEL D RETINAL THICKNESS ANALYZER (May 6, 2003)
  • K000731 — MODIFICATION TO RTA RETINAL THICKNESS ANALYZER (March 31, 2000)
  • K964137 — RTA RETINAL THICKNESS ANALYZER (February 3, 1997)
  • K930518 — TALIA LASER SLIT (January 25, 1994)

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